GE Healthcare, LLC: Medical Device Recall in 2012 - (Recall #: Z-0450-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: August 1, 2012

Date Posted: December 5, 2012

Recall Number: Z-0450-2013

Event ID: 63212

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.

Status: Terminated

Product Quantity: 217 total installed in the US

Code Information:

Model No - 5421698

Distribution Pattern:

Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated