Ge Hangwei Medical Systems Co., Ltd.
West Area of Building No.3, No.1 Yongchang North Road, Beijing, CN
Registered product codes
22 product codes
Recent MDR events
191 on file
- OPTIMA 660Jul 1, 2026Malfunction9613445-2026-00005
- REVOLUTIONApr 20, 2026Injury9613445-2026-00004
- PROTEUSApr 9, 2026Injury9613445-2026-00003
- OPTIMAJan 28, 2026Death9613445-2026-00002
- REVOLUTIONJan 13, 2026Injury9613445-2026-00001
- REVOLUTIONOct 23, 2025Injury9613445-2025-00007
- REVOLUTIONJul 30, 2025Injury9613445-2025-00006
- PROTEUSJul 11, 2025Malfunction9613445-2025-00005
- PROTEUSMay 9, 2025Malfunction9613445-2025-00004
- DISCOVERY 670 NM/CTMar 12, 2025Malfunction9613445-2025-00003
Recalls
2 on file
- Open, ClassifiedDec 14, 2023
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.
View FDA record ↗ - Open, ClassifiedDec 14, 2023
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.
View FDA record ↗
Compliance history
Matched by FEI 3002175190.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.