GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-2449-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Proteus XR/a (SlOK : K993090)

Product Classification:

Class II

Date Initiated: August 9, 2019

Date Posted: October 2, 2019

Recall Number: Z-2449-2019

Event ID: 83647

Reason for Recall:

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

Status: Ongoing

Product Quantity: 647 US; 167 OUS

Code Information:

console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)

Distribution Pattern:

Worldwide - US Nationwide

Voluntary or Mandated:

FDA Mandated