GE Discovery MR950 MRI system
- Company
- Ge Healthcare
- Recall Initiated
- October 24, 2014
- Posted
- May 1, 2015
- Terminated
- May 6, 2015
- Recall Number
- Z-1395-2015
- Quantity
- 5 units (2 in US)
- Firm Location
- Waukesha, WI
Reason for Recall
The alignment lasers are missing the labels required by radiation safety regulations.
Distribution
US Distribution to the state of CA., and Internationally to Italy and Japan.
Lot / Code Info
Model Number - Discovery MR950
Root Cause
Error in labeling
Action Taken
GE Planned action(s) to repair defect or to bring product into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 5 units consists of the following: 1. New labels will be mailed to all purchasers, with instructions to apply the label in the appropriate location on the unit, or a GE field engineer will be sent to each user site to complete the correction. 2. All mailings and service calls will be made at no cost to the purchaser. 3. The corrections will be completed by August 1, 2015. If you have any questions, please contact your local Service Representative or call 1 (800) 437-1171.