Recall Z-1395-2015— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2014-10-24, terminated 2015-05-06. FDA's recall record names no specific 510(k) clearance for this event. Product: GE Discovery MR950 MRI system. Reason: The alignment lasers are missing the labels required by radiation safety regulations..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-24
- Terminated
- 2015-05-06
- Firm location
- Waukesha, WI, United States
Product description
GE Discovery MR950 MRI system
Reason for recall
The alignment lasers are missing the labels required by radiation safety regulations.
Data sourced from openFDA. This site is unofficial and independent of the FDA.