Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
FDA device recall Z-0284-2024 · posted 2023-11-09 · Completed
Recall details
- Recalling firm
- Philips Ultrasound, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Completed
- Product code
- IYN
- Quantity affected
- 7 systems
- Distribution
- US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
- Date initiated
- 2023-10-09
- Date posted
- 2023-11-09
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EPIQ Series Diagnostic Ultrasound System (K231190) | Philips Ultrasound, LLC | 2023-05-12 |