FDA Device recall Z-1915-2016
GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications by Ge Healthcare, citing GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT crad….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1915-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-09 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE 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
GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000437624CN0 N/A 00000439694CN1 N/A 00000439777CN4 N/A 00000439930CN9 N/A 00000441…Mfg Lot or Serial # System ID 00000437624CN0 N/A 00000439694CN1 N/A 00000439777CN4 N/A 00000439930CN9 N/A 00000441224CN3 203688ERREV1 00000441575CN8 N/A 00000441624CN4 N/A 00000441648CN3 N/A 00000441916CN4 469841REVO 00000442032CN9 N/A 00000442124CN4 N/A 00000442219CN2 N/A 00000442443CN8 N/A 00000443993CN1 N/A 00000444530CN0 N/A 00000445085CN4 N/A 00000438756CN9 309655REVCT 00000439113CN2 212241REVCT 00000439205CN6 415476MCT3 00000439287CN4 415476MCT2 00000439836CN8 215662CTREV 00000440713CN6 815226RVCT 00000441459CN5 206320REV 00000441716CN8 808522RCT 00000442228CN3 281274REV 00000442994CN0 919684REVCT 00000443379CN3 608263REVCT 00000443664CN8 409772CT7 00000443900CN6 402481BEREVCT 00000444165CN5 AM14CFI65 00000444175CN4 801507REV 00000444253CN9 704384REV 00000444745CN4 808KMCCT 00000444872CN6 316268REVCT 00000445059CN9 310222REVO 438369CN1 206598REV1 438902CN9 801662REV1 439823CN6 408356RV1 439835CN0 503216SREV 441040cn3 215952CTREV 441064CN3 |
|---|
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-1915-2016%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.