openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Code information
Model No - 5555000-5
Distribution pattern
Nationwide distribution
device · product 2 of 3
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Code information
Model No - 5555000-6
Distribution pattern
Nationwide distribution
device · product 3 of 3
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
