FDA Device recall Z-1129-2021
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
- FDA Device
- Class II
- terminated
- Published 2021-02-24
On 2021-02-24 the FDA classified a Class II recall of System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition by Ge Healthcare, citing GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protecto….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1129-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-17 |
| Published | 2021-02-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Reason
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
Identifiers
| code_info | Model Numbers: 5590000-20: REV2A1900002CN, REV2A2000013CN, REV2A2000025CN, REV2A2000006CN, REV2A2000003CN, REV2A2000…Model Numbers: 5590000-20: REV2A1900002CN, REV2A2000013CN, REV2A2000025CN, REV2A2000006CN, REV2A2000003CN, REV2A2000015CN, REV2A1900003CN, REV2A2000007CN, REV2A2000022CN, REV2A2000010CN, REV2A2000030CN, REV2A2000029CN, REV2A2000017CN, REV2A2000001CN, REV2A2000002CN, REV2A2000031CN, REV2A2000020CN, REV2A2000024CN, REV2A2000023CN, REV2A2000012CN, REV2A2000016CN, REV2A1900001CN, REV2A2000027CN, REV2A2000028CN, REV2A2000018CN, REV2A1900005CN, REV2A2000009CN, REV2A2000026CN, REV2A2000021CN, REV2A2000011CN 5590000-21: xxx, xxx, xxx* (66 units) *serial number information current as of 01/21/2021. |
|---|
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-1129-2021%22
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