GE Hangwei Medical Systems, Co. LTD FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimatorClass IINov 7, 2023GE HealthCare has become aware of the potential that incorre	GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the	Class IIDevices	Nov 7, 2023
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimatorClass IINov 7, 2023GE HealthCare has become aware of the potential that incorre	GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the	Class IIDevices	Nov 7, 2023