EPIQ Elite PW Doppler: Check the Preset Before Any Board

Is this software 14.0 with the C5-1 abdominal vascular preset?

A weak pulsed-wave trace, or a sample gate that does not sit on the vessel the sonographer intended, can look like a probe fault or a front-end board fault. On this console it may instead be the August 2026 field notice. Check the software and the preset before anyone opens the cart or orders a part. The letter and the FDA record name a narrow population. A cart outside that population is not automatically a hardware failure, and a cart inside it is not fixed by a new C5-1. ^{1 2}

Separate the affected product from the use that must stop. The letter's identification section says EPIQ Elite systems operating on software 14.0 are impacted. The user instructions then limit the faulty behavior: a weak pulsed-wave signal when the C5-1 is used with the Abd Vasc tissue-specific preset, and only that combination on software 14.0. A 14.0 console is in the identified population even if today's exam never opened Abd Vasc. The clinical stop, until Philips loads the correction, is that one preset. ¹

The letter gives two ways to read the software version. During boot, the splash screen shows Release 14.0. On a system that has already started, press the Support button on the right side of the control panel, open System Information under System Management, and read the software version in the Software Information section. FDA recall Z-3249-2026 uses the same gate: all EPIQ Elite systems running software 14.0, model 795234. The record names 510(k) numbers K260123 and K260680. This page does not describe what those clearances changed. ^{1 2}

The notice does not name Affiniti, and it does not give this preset stop to a console whose System Information screen shows a release other than 14.0. Do not apply Abd Vasc as a cart-wide rule on an EPIQ 5, EPIQ 7, or CVx because the family name is similar. If the model label is not 795234, or the software is not Release 14.0, this letter is the wrong document. Software 9.0, 9.01, and 9.02 are not a hardware diagnosis either. Those versions appear on the older X5-1c reboot recall, which the EPIQ board symptom path already keeps in front of a power-supply order. ^{1 5}

What does the letter say the sample gate is doing?

The issue description is a display offset, not a measured board fault. When an EPIQ Elite on software 14.0 uses the C5-1 with the Abd Vasc preset in pulsed-wave Doppler, the visual sample-volume gate is slightly offset, shallower than the actual location of the pulsed-wave measurement. Under default conditions the letter says that offset is about 2 mm. FDA's reason line is the same mechanism in shorter words: the Doppler sample is displayed shallower than its actual measurement location and may make blood-flow velocity measurements inaccurate. The 2 mm sentence is in the letter. The FDA page does not reprint it, and this shop did not repeat the measurement. Keep the words approximate and under default conditions. ^{1 2}

The letter then splits the clinical effect by vessel size, and it does not give a single velocity error. In larger vessels, the defect may result in reduced signal, which the user may compensate for by increasing pulsed-wave gain. That sentence describes what a user may do. It is not the instructed workaround. The instructed action is to leave the C5-1 Abd Vasc preset. In smaller vessels or stenotic flow, the letter says the defect may underestimate the severity of stenosis. It also says the issue could delay diagnosis or treatment, and that inaccurate data may lead to misdiagnosis or an incorrect treatment decision if the finding is not identified or corroborated with other diagnostic tools. ¹

Philips states that there have been no customer complaints or reports of harm for this issue. That cuts against any account that treats the offset as a known injury series. It does not erase the letter's delay and misdiagnosis sentences, and it does not change the FDA classification. Z-3249-2026 is a Class 2 recall, status Open and Classified, which means the firm has started the correction and not every affected unit has been corrected. FDA lists the determined cause as a software design change. ^{1 2}

Figure 1 is an illustration of small vessels, not a tolerance band. The caption's ideal position, with the sample volume near the center of the lumen, is a weaker signal and a peak systolic velocity of 50.4 cm/s. The caption's offset position, described as slightly posterior to the vessel, is a stronger trace and a peak systolic velocity of 53.0 cm/s. Those two speeds are the drawing. They are not a repair limit, and they are not a specified bias this page will quote as the error. The issue description's sentence for smaller vessels and stenotic flow is underestimation of stenosis severity. The figure's offset drawing happens to show a higher velocity than its ideal drawing. Do not average those into one direction of error. ¹

Figure 2, the large-vessel illustration, points the other way from a simple off-center-means-slower story. The caption's ideal placement, in the center of the lumen, is a weak signal and not what the user would expect given the normal color Doppler signal. The caption says gain would typically be increased by the user. The offset placement, described as deep to the periphery of the vessel, shows a normal pulsed-wave trace. Do not teach, from this letter, that the defect moves the gate off the fastest streamline and therefore lowers the peak velocity. The letter does not say that. ¹

The issue description and the FDA reason both say the displayed gate is shallower than the measurement location. The figure captions use different spatial words for the drawings: slightly posterior, and deep to the periphery. This page does not merge those captions into an acoustic-delay fault, a beamformer timing error, or a channel-board diagnosis. Those mechanisms are not in the letter. If a later Philips revision changes the description, use the revision. The copy read for this page is the four-page PDF hosted by Swissmedic, not a file downloaded from philips.com. ^{1 2}

What should users stop, and what may they keep using?

Regulator indexes do not all say the same thing, and a broader headline is not a second technical description. On 12 August 2026 the Danish Medicines Agency indexed reference 2026-PD-US-009. The page title says Philips is informing users of a software error with an instruction about temporary cessation of use of the Philips EPIQ Elite. The summary sentence repeats that wording for the equipment, midlertidig ophør af brug af udstyret, and tells the reader to read the manufacturer's notice. The index does not restate the preset limit. A team that stops at the title can lock out a scanner the letter still allows in service. ⁴

The MHRA list for 10 to 14 August 2026, issued 18 August 2026, is the opposite kind of index. It names Philips EPIQ Elite, model 795234, manufacturer reference 2026-PD-US-009, and MHRA reference 40497029, under ultrasound system, imaging, general purpose. It does not describe the sample gate, the preset to stop, or the software check. MHRA says a field safety notice from a manufacturer must be acted on, and that the published list is for information. Questions about a particular notice go to the manufacturer. The list is a pointer. It is not the work instruction. ³

The letter and the FDA action text are the work instruction. Customers are advised not to use the C5-1 Abd Vasc tissue-specific preset because of the possibility of a weak pulsed-wave signal on an EPIQ Elite running software 14.0. Use a different tissue-specific preset within the C5-1. The examples printed in both the letter and the FDA action are Abd Gen and Abd Renal. The letter does not publish a full preset catalog, and those two names are examples, not a tested list of every other preset. The letter says the issue is restricted to the Abd Vasc preset with the C5-1 on EPIQ Elite software 14.0 only. Otherwise, continue to use the device in accordance with the instructions for use. That is not a sentence that separately clears elastography, TEE, or any mode the letter does not mention. It means the notice does not extend the stop beyond that combination, and remaining use stays under the instructions for use. ^{1 2}

Philips also asks the site to circulate the notice to all users, to post it near the affected units, and to return the completed response form no later than 30 days from receipt of the letter. The 30 days run from receipt, not from the 18 September 2026 FDA posting date. The form header reference is FCO79500850. Completing it confirms receipt, understanding, and that the information has been distributed to users of the EPIQ Elite. It does not close the technical issue. The technical correction is a different number. In the manufacturer-actions paragraph, Philips says it will implement a software correction free of charge, and that a Philips representative will contact the customer to schedule it, reference FCO79500580. The letter is signed by Ondrea Bermudez, Head of Quality, Ultrasound, and the actions line prints SRN US-MF-000002237. ¹

Use that contact path. The FDA record's additional-information line names Philips Image Guided Therapy Devices and a telephone number. The letter says to contact the local Philips representative, and it is an ultrasound notice. Do not treat the Image Guided Therapy line as the desk that schedules FCO79500580. For how a Class 2 correction differs from a count of injuries, the separate guide on how to read an ultrasound recall record covers classification and the limits of passive reports. Z-3249-2026 was posted after that census. Do not read this page as an update of the census. ²

Why is model 795234 not enough to identify the recall?

A CMMS search on model 795234, or on UDI (01)00884838107540, returns more than one Class 2 action. Z-3249-2026 and Z-1007-2026 can both show that model and that UDI. They are not the same event. Software version and transducer are what separate them. Product code does not: both records use IYN, system, imaging, pulsed doppler, ultrasonic. The recalling firm on both pages is Philips Ultrasound, LLC, in Bothell, and both pages print FEI 3019216. A firm match is not an event match. ^{2 5}

Z-3249-2026 is the preset correction. FDA posted it on 18 September 2026. The firm initiated it on 7 August 2026. The recall number is Z-3249-2026, event 99706. Status on 30 September 2026 was Open and Classified. The product line is the Philips EPIQ Elite diagnostic ultrasound system, model 795234, all units running software 14.0. Quantity in commerce is 219 units. Distribution is worldwide, including named U.S. states and countries in Europe and Asia. Denmark, Switzerland, and the United Kingdom are on that list, which is why those regulators' indexes are in view. The 219 units are not a count of injuries, and the letter's statement of no complaints or reports of harm is not a rate. ²

The same FDA page prints five UDIs. A search that uses only the shared one will miss the other four, and a search that treats every UDI as the X5-1c recall will open the wrong action. The five identifiers on Z-3249-2026 are (01)00884838102514, (01)00884838107540, (01)00884838114159, (01)00884838124912, and (01)00884838128125. The identifier that also appears on Z-1007-2026 for model 795234 is (01)00884838107540. The other four are not in the code list of the older record. That comparison is only between these two pages. ^{2 5}

Mixing the rows sends the part to the wrong bench. An unexpected reboot with an X5-1c on software 9.0, 9.01, or 9.02 is the completed action, not a reason to stop Abd Vasc on a 14.0 console. A shallow sample gate on software 14.0 with the C5-1 Abd Vasc preset is the open action, not a reason to condemn a power supply because model 795234 once had a reboot recall. The EPIQ board symptom path already tells the reader to check Z-1007-2026 before ordering a power supply for that reboot. This page does not repeat that action's connector instruction. ^{2 5}

When does the trace become a board or probe quote?

The preset gate is a stop, not a proof that every board in the cart is healthy. Use it to decide whether this letter explains the trace. If it does, do not order a part. If it does not, this page is finished and a different page owns the hardware question. ¹

1. Leave Abd Vasc first. With the C5-1 still connected, open a C5-1 preset the letter names as an example, Abd Gen or Abd Renal, and repeat the pulsed-wave sample. If the gate sits where the measurement is and the trace is no longer the weak signal the letter describes, this notice explains the Abd Vasc finding. Stop. Do not order an acquisition board or a replacement C5-1 for that finding. A normal alternative preset does not certify every other board in the system.
2. If the same weak or misplaced pulsed-wave trace remains on Abd Gen or Abd Renal, the letter does not explain it. Write down Release 14.0 or whatever the Software Information screen actually shows, the preset name, and the probe model. Then leave this notice.
3. If the probe is not a C5-1, or the software is not Release 14.0, this notice does not explain the trace. Do not convert that miss into an acquisition-board order from this page. A reboot with an X5-1c on software 9.0, 9.01, or 9.02 is the older recall, owned by the EPIQ board path.
4. A missing continuous-wave trace, with B-mode and color still present, is a different decision. That path is the continuous-wave Doppler decision. This letter is a pulsed-wave sample-gate offset on one preset. Do not use the continuous-wave page to interpret 2026-PD-US-009, and do not use this letter to explain a missing continuous-wave pencil-probe trace.
5. If the fault stays with the C5-1 on every preset the letter allows, including after the probe is tried on another port or another console, the next page is the probe versus scanner artifact path. This notice is not a probe-damage finding. The letter does not describe lens condition, element dropout, or cable damage, and this page does not add those tests.
6. Do not raise pulsed-wave gain as the correction. The letter says a user may do that when a large vessel looks weak. The instructed action remains: leave the C5-1 Abd Vasc preset.

There is no photographed C5-1 row in the parts catalog, so this page is not a probe offer. EPIQ boards that are in the photographed catalog are listed on the Philips EPIQ model page. Match the etched label before anyone treats a catalog row as the part in the cart. A catalog row is not evidence that an acquisition board fixes the Abd Vasc offset. Current stock is whatever the catalog shows on the day of the quote.

Where Rongtao fits, and where it does not

Rongtao Medical repairs ultrasound boards and supplies tested parts for facilities, independent service organizations, and distributors. It is not Philips Ultrasound, and it is not the representative who installs field-change order FCO79500580. The letter says a Philips representative will contact the customer to schedule that correction, free of charge. That free correction is not a Rongtao warranty term, and a Rongtao repair warranty is not the Philips software load. The parts warranty and RMA terms page is where the repair warranty is spelled out. ¹

Rongtao does not sell an acquisition board, a channel board, or a transducer as the fix for this notice. If the console is an EPIQ Elite on Release 14.0 and the weak or shallow gate was made with the C5-1 Abd Vasc preset, the correction path is the letter: stop that preset and wait for FCO79500580. Ordering a part skips the only check the letter asks the service team to make.

Rongtao does fit after that gate has failed and the labeled assembly is a board the shop can test. Published service terms are a 3,000 m² technical and warehousing center in Guangzhou, 35+ senior engineers, service in 140+ countries, a typical turnaround of 5 to 8 business days, and a typical 90-day warranty. Every repaired board runs for 48 hours inside an actual ultrasound system before release. Those terms are confirmed by the item and the service. They are not a promise that the test system is the same EPIQ Elite configuration as the customer's cart, and they are not a software-install service.

Quote-ready technical handoff checklist

Send a hardware quote only after the preset gate has failed. Use the contact form and include the facts that keep this notice from being confused with a board fault:

1. Console identity: EPIQ Elite or the name on the label, model number, and serial number. Say whether the label reads 795234.
2. Software version from the splash screen or from Support, System Management, System Information. Quote the release exactly. Do not write 14.0 unless that screen shows it.
3. The preset in use when the trace failed, and what happened after switching the C5-1 from Abd Vasc to Abd Gen or Abd Renal.
4. The probe model. If the fault stayed with one probe, say whether it followed that probe to another port or another console.
5. The board or power-supply label: manufacturer part number, revision, and photographs of both sides of the assembly, including the barcode. Do not send a model name in place of the etched number.
6. The symptom in the operator's words, plus any error text copied from the screen. Do not substitute an error code from a different EPIQ note.
7. Quantity and destination country. Philips's free software correction is not part of this quote.

Frequently asked questions

Does the EPIQ Elite Doppler notice ground the whole scanner?
No. The Danish index title and its summary sentence say temporary cessation of use of the equipment. The Philips letter does not. It says not to use the C5-1 Abd Vasc preset on software 14.0, and that the device may otherwise continue in use under the instructions for use. Do not lock out every EPIQ Elite because an index line is broader than the letter. ^{1 4}

Which preset does Philips say to stop using?
The C5-1 Abd Vasc tissue-specific preset, on EPIQ Elite software 14.0. The letter's examples of other C5-1 presets are Abd Gen and Abd Renal. It says the issue is restricted to that Abd Vasc combination. It does not publish a complete list of safe presets. ¹

How do I see whether the console is on software 14.0?
The boot splash screen shows Release 14.0 when that is the installed release. After boot, press the Support button on the right side of the control panel, open System Information under System Management, and read the Software Information section. If that screen does not show 14.0, this notice does not explain the trace. ¹

Is Z-3249-2026 the same action as the X5-1c reboot recall?
No. Z-3249-2026 is the open Class 2 correction for the C5-1 pulsed-wave sample gate on software 14.0, model 795234. Z-1007-2026 is the completed Class 2 action for an unexpected reboot that may damage the X5-1c, on software 9.0, 9.01, and 9.02, across several EPIQ model numbers including 795234. They can share UDI (01)00884838107540. Software version and probe model separate them. ^{2 5}

Will a new C5-1 or an acquisition board fix this offset?
No. The letter describes a software preset issue on Release 14.0. Replacing the C5-1 or an acquisition board does not change the Abd Vasc calculation the letter describes. The correction Philips describes is the software load under FCO79500580, or, until that load, a different C5-1 preset such as Abd Gen or Abd Renal. ¹

Who installs the software correction?
The letter says a Philips representative will contact the customer to schedule the free correction, reference FCO79500580. Rongtao does not install it. The response form, reference FCO79500850, goes back to Philips within 30 days of receipt. The FDA page's additional-contact line names Philips Image Guided Therapy Devices. Use the letter's local Philips representative for this ultrasound correction. ^{1 2}