GE Healthcare: Medical Device Recall in 2015 - (Recall #: Z-1406-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx

Product Classification:

Class II

Date Initiated: December 19, 2014

Date Posted: May 6, 2015

Recall Number: Z-1406-2015

Event ID: 70924

Reason for Recall:

An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.

Status: Terminated

Product Quantity: 6 units in US

Code Information:

OptimaXR200amx PN 5555000-3, PN5555000-4

Distribution Pattern:

US Distribution to the states of: AZ, FL, GA, MO and WI.

Voluntary or Mandated:

Voluntary: Firm initiated