GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
FDA Recall Z-1993-2012 · Posted 2012-07-19
Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIZL
Date Initiated2012-04-04
Date Terminated2013-01-10
Product Quantity254 units have been shipped to/installed in the U.S.
Reason for Recall
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.
Firm Action
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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Worldwide Distribution (USA) nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.