FDA Device recall Z-0376-2017
Philips Healthcare System X-ray Tomography Computed
- FDA Device
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of Philips Healthcare System X-ray Tomography Computed by Philips Electronics North America, citing 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 fai….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0376-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-15 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
Philips Healthcare System X-ray Tomography Computed :
Reason
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.
Identifiers
| code_info | Ingenuity CT, Ingenuity Core, Ingenuity Core 128. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0376-2017%22
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