Philips Affiniti 70 — Class II medical device recall Z-0284-2024
Completed recall by Philips Ultrasound, Inc., reported 2023-11-15, distributed in AZ, CA, CT, FL, GA, ID, IL, KY…. Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a d
| Recall number | Z-0284-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, Inc., Bothell, WA, United States |
| Recall initiated | 2023-10-09 |
| Classified | 2023-11-08 |
| Reported by FDA | 2023-11-15 |
| Distributed | AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA |
| Countries outside the US | CA |
| Quantity | 7 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838106611 |
| Serial numbers | US217F0292, US523F1496, US523F1497, US523F1930, US723F1377, US918F1158, US918F1159 |
| Model numbers | 795210 |
Product
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0284-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.