GE Healthcare, LLC: Medical Device Recall in 2012 - (Recall #: Z-2256-2012)

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:

Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.

Product Classification:

Class II

Date Initiated: July 10, 2012

Date Posted: September 19, 2012

Recall Number: Z-2256-2012

Event ID: 62946

Reason for Recall:

Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.

Status: Terminated

Product Quantity: 254 total in the US

Code Information:

Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.

Distribution Pattern:

Worldwide Distribution -- USA (nationwide) Distribution

Voluntary or Mandated:

Voluntary: Firm initiated