PlainRecalls
FDA Devices Moderate Class II Terminated

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).

Reported: December 5, 2012 Initiated: August 1, 2012 #Z-0450-2013

Product Description

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).

Reason for Recall

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
217 total installed in the US
Distribution
Nationwide distribution
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
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).. Recalled by GE Healthcare, LLC. Units affected: 217 total installed in the US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 5, 2012. Severity: Moderate. Recall number: Z-0450-2013.

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