X-ray system overhead suspension components may fall due to incorrect bolt torque
GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a structural defect with potential for component failure. No injuries or hospitalizations have been reported. Per the rubric, a risk-of-harm product without reported injury receives a High severity rating.
Plain-English summary
GE HealthCare has identified a potential safety issue affecting Definium Tempo and Definium Tempo Pro X-ray systems. Certain units of these systems may have been assembled with incorrect torque applied to bolts in the Overhead Tube Suspension (OTS) assembly. This improper assembly could result in the fall of elements of the OTS assembly.
The recall affects 68 units that have been distributed nationwide across the United States. Affected systems are identified by specific System IDs and Universal Device Identifiers (UDI) codes provided by the manufacturer.
The recalled product
- Product
- 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 cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
- Manufacturer
- GE Hangwei Medical Systems, Co. LTD
- Category
- Medical Device — X-ray System
- Hazard
- fall-hazard
- mechanical-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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