GE Healthcare Optima Mobile Xray System 의 리콜

Recall

62527

Class 2

Z-1993-2012

2012-04-04

2012-07-19

Terminated

United States

2013-01-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110854

Ge healthcare has become aware of a software issue on the interface of the mobile radiographic product, optima xr200amx, ond optima xr220amx related to visual indication as mandated by the us code of federal regulations (21cfr) and iec 60601-1-3.

GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to the user or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the firmware on the system to address the issue. Your proposed corrective action plan (CAP) (Field Modification Instructions 10865) describes the rework plan that GEHC Engineers will make to the imaging system to return it to compliance with the applicable performance standard. It appears to adequately address the problem and is hereby approved.