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: 134 units Lot/code info: UDI 01001952781183561122100021DX3SS2200214HL, System ID 205620DEF1; UDI 01001952781183561122080021DX3SS2200165HL, System ID 205783DEF1; UDI 01001952781183561122100021DX3SS2200211HL, System ID 205387DEF1; UDI 01001952781183561122110021DX3SS2200216HL, System ID 623ABZARRWTMPO; UDI 01001952781183561122120021DX3SS2300001HL, System ID 928263DEF1; UDI 01001952781183561123040021DX3SS2300103HL, System ID 520NOGTEMPO; UDI 01001952781183561122100021DX3SS2200210HL, System ID 602ABZSCOTTSTMPO; UDI 01001952781183561122110021DX3SS2200223HL, System ID 602ABZCNTRLTMPO; UDI 01001952781183561123030021DX3SS2300082HL, System ID 209324DEF1; UDI 01001952781183561123020021DX3SS2300046HL, System ID 209497DEF1; UDI 01001952781183561122080021DX3SS2200158HL, System ID 303827DEF1; UDI 01001952781183561123010021DX3SS2300030HL, System ID 970242DEF1; UDI 01001952781183561122080021DX3SS2200168HL, System ID 303457DEF1; UDI 01001952781183561122030021DX3SS2200047HL, System ID 860545TEMPO1; UDI 01001952781183561122030021DX3SS2200046HL, System ID 860545TEMPO2; UDI 01001952781183561122010021DX3SS2200013HL, System ID 203838TEMPO; UDI 01001952781183561122070021DX3SS2200117HL, System ID 860889TEMPO; UDI 01001952781183561123010021DX3SS2300013HL, System ID 202444DEF2; UDI 01001952781183561123040021DX3SS2300135HL, System ID 202877TEM1; UDI 01001952781183561123020021DX3SS2300039HL, System ID 813681DEF1; UDI 01001952780702651122030021DX3SS2200032HL, System ID AHMGCTEM1; UDI 01001952781183561123030021DX3SS2300098HL, Syste

Source

Official record: FDA (Device enforcement) ↗

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