PlainRecalls
FDA Devices Moderate Class II Terminated

GE Discovery MR950 MRI system

Reported: May 13, 2015 Initiated: October 24, 2014 #Z-1395-2015

Product Description

GE Discovery MR950 MRI system

Reason for Recall

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

Details

Recalling Firm
GE Healthcare
Units Affected
5 units (2 in US)
Distribution
US Distribution to the state of CA., and Internationally to Italy and Japan.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
GE Discovery MR950 MRI system. Recalled by GE Healthcare. Units affected: 5 units (2 in US).
Why was this product recalled?
The alignment lasers are missing the labels required by radiation safety regulations.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 13, 2015. Severity: Moderate. Recall number: Z-1395-2015.