Recall archive / FDA device enforcement
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 — FDA record Z-0284-2024
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 9, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Philips Ultrasound, Inc.
- Quantity
- 7 systems
- Agency-reported status
- Completed
- Source record identifier
- Z-0284-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 15, 2023
- Recall initiation date
- Oct 9, 2023
- Center classification date
- Nov 8, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.