Philips EPIQ Diagnostic Ultrasound System Models: EPIQ… recallZ-0283-2024 · Philips Ultrasound, Inc. · initiated Oct 9, 2023
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Ultrasound, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
FDA root cause category: Software design
What the company is doing
On October 9, 2023, Philips issued a Urgent Medical Device Correction notification to affected consignees. Philips asked consignees to take the following actions: 1. Identify if your firm has an affected product. 2. In the 2D tab in the system touchscreen, disable the AutoSCAN feature every time a transducer or a Transducer preset is selected to prevent the system from potentially experiencing image lag issue. The AutoSCAN feature is disabled when the button is not highlighted in amber. 3. Please complete and return the attached response form to Philips promptly and no later than 15 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 4. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) and ensure the letter is in a place likely to be seen/viewed. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, or by regular mail, or by fax.
Recall details
- Recall number
- Z-0283-2024
- Status
- Completed
- Initiated by the company
- Oct 9, 2023
- Posted by the FDA
- Nov 9, 2023
- Recalling firm
- Philips Ultrasound, Inc.
- Quantity
- 83 systems
- Product code
- IYN
- FDA submissions
- K231190
- Distribution
- US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
Product description
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Following model numbers and serial numbers operating with software version 10.0: Model 795200/UDI:(01)00884838047693/Serial numbers: US818B1520 US115B0264 USD14B0996 USN18B0465 US915B0649 US516B0839 US516B0840 US516B0841 US617B1185 US617B1186 US617B1187 US318B2182 USN19B1084 USD13B0543 US419B1858 US419B1860 US419B1949; Model 795201/UDI:(01)00884838047693/Serial Number: USN16B0579; Model # 795202/UDI: (01)00884838047693/ Serial Numbers: US416B1186 US813B0429 US813B0430 US813B0432 USD16B1124 USD16B1126 USD16B1129 US419B1141 US419B1142 US419B1143 US419B1289 USO18B1195; Model 795204/ UDI: (01)00884838047686/ Serial Numbers: US220C0963 US818C1422 US818C1432 US818C1433 US818C1434 US719C0684; model # 795206/ UDI: (01)00884838047686/ Serial Numbers: USD16C1116 USD17C0754 USD18C0039 USO15C0951 US320C0864 Model # 795231/ UDI: (01)00884838114135/ Serial numbers: US723B1124 US120B0345 US120B0348 US120B1131 US723B1125 US723B1121 US723B1122 US723B1123; Model # 795234/UDI: (01)00884838107540/ Serial numbers: USO22B0941 US322B0678 US322B0676 US723B1023 US723B1126 US723B1024 US723B1022 US723B1128 US723B1127 US423B1238 US723B1021 US521B1455 US723B1017 US323B2026 US723B1018 US723B1019 US223B1718 US223B1719 US223B1720 USD22B0063 US323B0675 US723B1020 US523B0298 US523B0299 US523B0300 US523B2699 US523B2700 US523B2701 US523B2702 US523B2703 US523B2704 US523B2705 US523B2873 US523B2872
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- EPIQ 7 Diagnostic Ultrasound System 989605386721Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls2 deaths146 reports
- EPIQ Elite Diagnostic Ultrasound System 795234Philips Ultrasound LLC · System, Image Processing, Radiological3 recalls39 reports
- EPIQ 5 Diagnostic Ultrasound System 989605408541Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic2 recalls68 reports
- EPIQ Diagnostic Ultrasound System 795231Philips Ultrasound LLC · System, Imaging, Pulsed Doppler, Ultrasonic1 recall3 reports
Product lines
- EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound LLC · 5 models · 77 reports · 2 recalls
- EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound LLC · 5 models · 330 reports · 3 recalls
- EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLC · 9 models · 281 reports · 5 recalls
- EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLC · 5 models · 105 reports · 3 recalls
Other products in the same recall event
The FDA groups related products into one recall event (event 93218).
- Z-0284-2024 · CompletedPhilips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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