Philips Ultrasound Inc Recall 88625
Description: Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Philips Ultrasound Inc Recall 88625 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0071-2022 |
| Event ID | 88625 |
| Event Description | Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only, |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, MA, MD, MI, MS, NC, NY, OH, VA, WA and the countries of Australia, Portugal, Netherlands, Canada, Netherlands, Germany. |
| Quantity | 1 unit |
| Recall 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. |
| Device Classification | 20211013 |
| Device Code Info | Affected Serial Number/UDI numbers: US92010594 (01)00884838098015(21)US92010594 |
| Center Classification Date | 20211007 |
| Recall Initiation Date | 20210819 |
| Recalling Firm | Philips Ultrasound Inc |
| Initial Notification | Letter |
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