FDA Device recall Z-0768-2016

GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images

FDA Device
Class II
terminated
Published 2016-02-17

On 2016-02-17 the FDA classified a Class II recall of GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images by Ge Medical Systems, citing potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks.….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0768-2016
Classification	Class II
Status	terminated
Initiated	2015-12-23
Published	2016-02-17
Last updated	2026-09-13 11:54 UTC
Company	Ge Medical Systems
Distribution	PR, WA

Product

GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.

Reason

Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.

Identifiers

code_info	Lot or Serial numbers including but not limited to: 00001033715WK2, 12535HL3, 00000078321HL7, 00000096815HL6, 00000081… Lot or Serial numbers including but not limited to: 00001033715WK2, 12535HL3, 00000078321HL7, 00000096815HL6, 00000081147HL1, 00001032621WK3, 00000092076HL9, 00000092382HL1, 00000460115GE9, 00000079932HL0, D3s14793, 00000088642HL4, 116635HL4, 120632HL5, GEGR2411, GEGR5073, 00001027151WK8, 00000129105HL3, 261417HP0, 261416HP2, 1035189WK8, 00000084720HL2, 00000087109HL5, 00000100735HL0, 121206HL7, 125007HL5, 125019HL0, 1028231WK7, 00000126237HL7, 00000102072HL6, 00000092394HL6, 00000115802HL1, 124167HL8, 00001033721WK0, 00000108520HL8, 00000087928HL8, 00000111794HL4, 00000110657HL4, 00000092629HL5, 119090HL9, 00000442129GE3, 00000128179HL9, 00000110710HL1, 83621HL3, 00000082207HL2, 1034762WK3, 00000081499HL6, 00000088705HL9, 00000085601HL3, 00001031247WK8, 00000084721HL0, 00000084410HL0, 00000086179HL9, 1033866WK3, 00000084286HL4, 00000096817HL2, 00000092948HL9, 00000106841HL0, 00000105475HL8, 00001033220WK3, 00000106072HL2, 00000110662HL4, 00000106055HL7, 00000008789HL5, 00000084415HL9

code_info

Lot or Serial numbers including but not limited to: 00001033715WK2, 12535HL3, 00000078321HL7, 00000096815HL6, 00000081…

Lot or Serial numbers including but not limited to: 00001033715WK2, 12535HL3, 00000078321HL7, 00000096815HL6, 00000081147HL1, 00001032621WK3, 00000092076HL9, 00000092382HL1, 00000460115GE9, 00000079932HL0, D3s14793, 00000088642HL4, 116635HL4, 120632HL5, GEGR2411, GEGR5073, 00001027151WK8, 00000129105HL3, 261417HP0, 261416HP2, 1035189WK8, 00000084720HL2, 00000087109HL5, 00000100735HL0, 121206HL7, 125007HL5, 125019HL0, 1028231WK7, 00000126237HL7, 00000102072HL6, 00000092394HL6, 00000115802HL1, 124167HL8, 00001033721WK0, 00000108520HL8, 00000087928HL8, 00000111794HL4, 00000110657HL4, 00000092629HL5, 119090HL9, 00000442129GE3, 00000128179HL9, 00000110710HL1, 83621HL3, 00000082207HL2, 1034762WK3, 00000081499HL6, 00000088705HL9, 00000085601HL3, 00001031247WK8, 00000084721HL0, 00000084410HL0, 00000086179HL9, 1033866WK3, 00000084286HL4, 00000096817HL2, 00000092948HL9, 00000106841HL0, 00000105475HL8, 00001033220WK3, 00000106072HL2, 00000110662HL4, 00000106055HL7, 00000008789HL5, 00000084415HL9

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-0768-2016%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.