GE Healthcare, LLC: Medical Device Recall in 2012 - (Recall #: Z-0198-2013)

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 220amx Mobile general purpose radiographic imaging of the human head and body.

Product Classification:

Class II

Date Initiated: September 20, 2012

Date Posted: November 28, 2012

Recall Number: Z-0198-2013

Event ID: 63597

Reason for Recall:

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.

Status: Terminated

Product Quantity: 364 total units installed in US

Code Information:

part numbers: 5555000-5, 5555000-6

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated