GE Hangwei Medical Systems, Co. LTD: The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cl

Hazard

GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.

Details from the source

Reason for recall: GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly. Distribution: US Nationwide distribution. Quantity: 68 units Lot/code info: UDI 01001952781183561122100021DX3SS2200214HLSystem ID 205620DEF1; UDI 01001952781183561122100021DX3SS2200210HLSystem ID 602ABZSCOTTSTMPO; UDI 01001952780702651122060021DX3SS2200096HLSystem ID 408885TEMP1; UDI 01001952781183561122080021DX3SS2200158HLSystem ID 303827DEF1; UDI 01001952781183561122100021DX3SS2200199HLSystem ID 561514DEF1; UDI 01001952781183561123020021DX3SS2300053HLSystem ID 727300DEF; UDI 01001952780702651122100021DX3SS2200194HLSystem ID 229340DEF; UDI 01001952780702651122090021DX3SS2200173HLSystem ID 770219DEF1; UDI 01001952780702651122090021DX3SS2200177HLSystem ID 770219DEF2; UDI Not AvailableSystem ID 912530OPT; UDI 01001952781183561122110021DX3SS2200243HLSystem ID 404778STKTEM1; UDI 01001952781183561122100021DX3SS2200185HLSystem ID 208265DEF1; UDI 01001952781183561122080021DX3SS2200141HLSystem ID NMNMHTEMP1; UDI 01001952780702651123020021DX3SS2300054HLSystem ID NMNMHTEMP2; UDI 01001952781183561122050021DX3SS2200071HLSystem ID 847842TEMP; UDI 01001952781183561123060021DX3SS2300164HLSystem ID 913588TEMPO; UDI 01001952781183561122080021DX3SS2200162HLSystem ID 337261DEF1; UDI 01001952781183561122100021DX3SS2200189HLSystem ID 337261DEF2; UDI 01001952780702651123040021DX3SS2300121HLSystem ID 318495DEF1; UDI 01001952780702651123020021DX3SS2300037HLSystem ID 617SH4332; UDI 01001952781183561122110021DX3SS2200239HLSystem ID 248937DEF1; UDI 01001952781183561122110021DX3SS2200238HLSystem ID 313966DEF1; UDI 01001952780702651123070021DX3SS2300193HLSystem ID 906341DEF1; UD

Source

Official record: FDA (Device enforcement) ↗

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