GE Healthcare, LLC: Medical Device Recall in 2012 - (Recall #: Z-1993-2012)

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 Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )

Product Classification:

Class II

Date Initiated: April 4, 2012

Date Posted: July 25, 2012

Recall Number: Z-1993-2012

Event ID: 62527

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.

Status: Terminated

Product Quantity: 254 units have been shipped to/installed in the U.S.

Code Information:

Model Numbers Optima XR200 15kw Optima XR 200 30kw Optima XR 220 15kw Optima XR 220 30kw

Distribution Pattern:

Worldwide Distribution (USA) nationwide

Voluntary or Mandated:

Voluntary: Firm initiated