FDA Device recall Z-0284-2024
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
- FDA Device
- Class II
- completed
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 by Philips Ultrasound, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0284-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-10-09 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Ultrasound |
| Distribution | AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA |
Product
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
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.
Identifiers
| code_info | Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US5…Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0284-2024%22
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