FDA Device recall Z-0071-2022
Philips Ultrasound, Inc
- FDA Device
- Class II
- terminated
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of Philips Ultrasound, Inc by Philips Ultrasound, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0071-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-19 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Reason
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.
Identifiers
| code_info | Affected Serial Number/UDI numbers: US92010594 (01)00884838098015(21)US92010594 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0071-2022%22
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