Philips Ultrasound — Class II medical device recall Z-0071-2022
Terminated recall by Philips Ultrasound Inc, reported 2021-10-13, distributed nationwide. Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of
| Recall number | Z-0071-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound Inc, Bothell, WA, United States |
| Recall initiated | 2021-08-19 |
| Classified | 2021-10-07 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2024-09-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, NL, PT |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00884838098015 |
| Model numbers | 100-240V, 50/60, 500VA, 795116, CE2797 |
Product
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Reason for recall
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
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-0071-2022. 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.