GE Healthcare: Medical Device Recall in 2015 - (Recall #: Z-1395-2015)

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 Discovery MR950 MRI system

Product Classification:

Class II

Date Initiated: October 24, 2014
Date Posted: May 13, 2015
Recall Number: Z-1395-2015
Event ID: 70701
Reason for Recall:

The alignment lasers are missing the labels required by radiation safety regulations.

Status: Terminated
Product Quantity: 5 units (2 in US)
Code Information:

Model Number - Discovery MR950

Distribution Pattern:

US Distribution to the state of CA., and Internationally to Italy and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated