GE Healthcare, LLC: It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.

Agency Publication Date: November 16, 2012

Affected Products

Product: GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.

part number: 5421698

Product: GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.

part numbers: 5555000-5, 5555000-6

Product: GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.

part numbers: 5555000-3, 5555000-4

Product: GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.

part numbers:5555000, 5555000-2

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 63597

Status: Resolved

Manufacturer: GE Healthcare, LLC

Manufactured In: United States

Units Affected: 4 products (364 total units installed in US)

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Sources: FDA iRES · Raw API Response

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