—#203692

Product

Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K231190
Affected lot / code info: Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Ultrasound, Inc.
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada

Timeline

Recall initiated: 2023-10-09
Posted by FDA: 2023-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203692. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.