Philips Healthcare System X-ray Tomography Computed : — Class II medical device recall Z-0376-2017
Terminated recall by Philips Electronics North America Corporation, reported 2016-11-30, distributed nationwide. It was discovered the patient support tabletop may fail to move in the horizontal direction when it is command
| Recall number | Z-0376-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2016-03-15 |
| Classified | 2016-11-22 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2020-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 1,363 |
| Reason classes | device malfunction |
Product
Philips Healthcare System X-ray Tomography Computed :
Reason for recall
It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
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-0376-2017. 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.