FDA Device recall Z-0401-2016

GE Healthcare, Revolution CT Scanners

FDA Device
Class II
terminated
Published 2015-12-16

On 2015-12-16 the FDA classified a Class II recall of GE Healthcare, Revolution CT Scanners by Ge Medical Systems, citing GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0401-2016
Classification	Class II
Status	terminated
Initiated	2015-10-23
Published	2015-12-16
Last updated	2026-09-13 11:53 UTC
Company	Ge Medical Systems
Distribution	US

Product

GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.

Reason

GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.

Identifiers

code_info	Mfg Lot or Serial # System ID 00000439632CN1 85109909185 00000439899CN6 83119074723 00000439913CN5 83119511730 0000… Mfg Lot or Serial # System ID 00000439632CN1 85109909185 00000439899CN6 83119074723 00000439913CN5 83119511730 00000441487CN6 83130644883 00000441818CN2 83132979115 00000443068CN2 GON-1510990 00000439432CN6 190059CT06 00000440338CN2 220078CT04 00000441574CN1 030355CT07 00000441779CN6 CT441683CN0 00000443105CN2 CT443038CN5 00000440186CN5 E416249CT1 00000437461CN7 519646REVO1 00000442492CN5 E416249CT2 00000443398CN3 905521RCT1 441961CN0 E416249CTE 442082CN4 403944RCT1 442220CN0 604988RCT1 442268CN9 416864RCT1 442573CN2 604682RCT1 AM13ECY81 00000440839CN9 82421040350 00000441053CN6 82421040345 00000441107CN0 82421050106 00000441563CN4 82421040359 00000441930CN5 82421040346 00000442030CN3 82421120479 00000442196CN2 82421030199 00000442749CN8 82421040369 00000443203CN5 82421300072 00000443282CN9 82421190317 00000443322CN3 82421120484 00000443348CN8 82421040370 442794CN4 GON-1510879 00000442517CN9 DK1051CT04 00000437837CN8 M2322254 00000440172CN5 P419290

code_info

Mfg Lot or Serial # System ID 00000439632CN1 85109909185 00000439899CN6 83119074723 00000439913CN5 83119511730 0000…

Mfg Lot or Serial # System ID 00000439632CN1 85109909185 00000439899CN6 83119074723 00000439913CN5 83119511730 00000441487CN6 83130644883 00000441818CN2 83132979115 00000443068CN2 GON-1510990 00000439432CN6 190059CT06 00000440338CN2 220078CT04 00000441574CN1 030355CT07 00000441779CN6 CT441683CN0 00000443105CN2 CT443038CN5 00000440186CN5 E416249CT1 00000437461CN7 519646REVO1 00000442492CN5 E416249CT2 00000443398CN3 905521RCT1 441961CN0 E416249CTE 442082CN4 403944RCT1 442220CN0 604988RCT1 442268CN9 416864RCT1 442573CN2 604682RCT1 AM13ECY81 00000440839CN9 82421040350 00000441053CN6 82421040345 00000441107CN0 82421050106 00000441563CN4 82421040359 00000441930CN5 82421040346 00000442030CN3 82421120479 00000442196CN2 82421030199 00000442749CN8 82421040369 00000443203CN5 82421300072 00000443282CN9 82421190317 00000443322CN3 82421120484 00000443348CN8 82421040370 442794CN4 GON-1510879 00000442517CN9 DK1051CT04 00000437837CN8 M2322254 00000440172CN5 P419290

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0401-2016%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.