FDA Device recall Z-1130-2021

System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES

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 CT, Revolution CT ES 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-1130-2021
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 CT, Revolution CT ES.

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: 00000441224CN3, 00000441064CN3, 00000442592CN2, 00000396676HP9, 00000442124CN4, 00000439287C… Model Numbers: 5590000: 00000441224CN3, 00000441064CN3, 00000442592CN2, 00000396676HP9, 00000442124CN4, 00000439287CN4, 00000439205CN6, 00000439823CN6, 00000445059CN9, 00000442706CN8, 00000444409CN7, 00000437624CN0, 00000443069CN0, 00000444745CN4, 00000441716CN8, 00000441624CN4, 00000441575CN8, 00000445084CN7, 00000444165CN5, 00000444872CN6, 00000443900CN6, 00000441262CN3, 00000439835CN0, 00000441040CN3, 00000439836CN8, 00000444398CN2, 00000442032CN9, 000003993CN1, 00000443227CN4, 00000443664CN8, 00000442228CN3, 00000445085CN4, 00000441916CN4, 00000444175CN4, 00000438902CN9, 00000439777CN4, 00000444913CN8, 00000441459CN5, 00000443379CN3, 00000441066CN8, 00000436942CN7, 00000442968CN4, 00000441694CN7, 00000439799CN8, 00000441381CN1, 00000441578CN2, 00000439505CN9, 00000440315CN0, 00000443038CN5, 00000441683CN0, 00000442044CN4, 00000442094CN9, 00000442443CN8, 00000443342CN1, 00000437410CN4, 00000440051CN1, 00000442219CN2, 00000442378CN6, 00000442163CN2, 00000441839CN8, 00000442412CN3,

code_info

Model Numbers: 5590000: 00000441224CN3, 00000441064CN3, 00000442592CN2, 00000396676HP9, 00000442124CN4, 00000439287C…

Model Numbers: 5590000: 00000441224CN3, 00000441064CN3, 00000442592CN2, 00000396676HP9, 00000442124CN4, 00000439287CN4, 00000439205CN6, 00000439823CN6, 00000445059CN9, 00000442706CN8, 00000444409CN7, 00000437624CN0, 00000443069CN0, 00000444745CN4, 00000441716CN8, 00000441624CN4, 00000441575CN8, 00000445084CN7, 00000444165CN5, 00000444872CN6, 00000443900CN6, 00000441262CN3, 00000439835CN0, 00000441040CN3, 00000439836CN8, 00000444398CN2, 00000442032CN9, 000003993CN1, 00000443227CN4, 00000443664CN8, 00000442228CN3, 00000445085CN4, 00000441916CN4, 00000444175CN4, 00000438902CN9, 00000439777CN4, 00000444913CN8, 00000441459CN5, 00000443379CN3, 00000441066CN8, 00000436942CN7, 00000442968CN4, 00000441694CN7, 00000439799CN8, 00000441381CN1, 00000441578CN2, 00000439505CN9, 00000440315CN0, 00000443038CN5, 00000441683CN0, 00000442044CN4, 00000442094CN9, 00000442443CN8, 00000443342CN1, 00000437410CN4, 00000440051CN1, 00000442219CN2, 00000442378CN6, 00000442163CN2, 00000441839CN8, 00000442412CN3,

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-1130-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.