Recall Z-1395-2015 ยท IWE Monitor, Patient Position, Light-Beam
GE Healthcare
GE Discovery MR950 MRI system
| Date | May 1, 2015 (initiated Oct 24, 2014) |
| Status | Terminated |
| Reason | The alignment lasers are missing the labels required by radiation safety regulations. |
| Root cause | Error in labeling |
| Action | 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 Servi |
| Quantity | 5 units (2 in US) |
| Distribution | US Distribution to the state of CA., and Internationally to Italy and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.