Recall Z-0284-2024 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, Inc.
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
| Date | Nov 9, 2023 (initiated Oct 9, 2023) |
| Status | Completed |
| Reason | 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 | Software design |
| Action | 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 day |
| Quantity | 7 systems |
| Distribution | US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231190 | EPIQ Series Diagnostic Ultrasound System Philips Ultrasound, LLC, May 12, 2023 |