GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Check against the official notice below — it lists the full affected range.
GE Medical Systems is recalling approximately 2,389 Optima XR220amx Mobile Digital Ready Radiographic Systems due to a potential failure of the safety latch mechanism in the column supporting the horizontal arm. The safety latch serves as a backup system in the unlikely event that the primary safety cable breaks. If the safety latch fails, the arm assembly could fall and cause bodily harm to a person.
The recalled systems were distributed worldwide, including throughout the United States, Puerto Rico, the U.S. Virgin Islands, Guam, and numerous other countries. The recall affects specific units identified by their lot or serial numbers. The source document does not specify what remedy consumers should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, Ethiopia, Finland, France, Germany, Gr Quantity: 2389 Lot/code info: 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, 00000084713HL7, 00000091763HL3, 00000093367HL1, 123730HL4, 00000109436HL6, 00000078816HL6, 00000078490HL0, 120816HL4, 00000124501HL8, 00000124510HL9, 123456789, 00000095656BT5, 118267HL4, 00000081688HL4, 00000110668HL1, 123737HL9, 00000081500HL1, 00000084711HL1, 00000085596HL5, 00000118284HL9, 00000124201HL5, 00000118285HL6, 00000118462HL1, 00000118282HL3, 00000104908HL9, 00000102090HL8, 00000100174HL2, 120182HL1, D3S141084, 00000100430HL8, 00000097754HL6, 114137HL3, 00000099201HL6, 00000099204
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.