GE Healthcare, LLC: Medical Device Recall in 2013 - (Recall #: Z-0761-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System

Product Classification:

Class II

Date Initiated: August 3, 2012

Date Posted: March 6, 2013

Recall Number: Z-0761-2013

Event ID: 64226

Reason for Recall:

GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.

Status: Terminated

Product Quantity: 9 units installed in US

Code Information:

Model Number : 5271997

Distribution Pattern:

Nationwide Distribution including NM, WY, FL, MO, MA, and MI.

Voluntary or Mandated:

Voluntary: Firm initiated