Recall Z-0148-2012 ยท IWE Monitor, Patient Position, Light-Beam
GE Healthcare, LLC
GE Healthcare Signa, Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR System, 1.5T Infinity TwinSpeed, Signa Lx; Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite 1.5T Expert; Signat 3T Infinity with Excite; Signa 3.0T with EXCITE; Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T; Signa HDx; Signa HDxt; Signa Vibrant;
| Date | Feb 8, 2012 (initiated Sep 15, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of missing labels on the alignment lasers. |
| Root cause | Labeling design |
| Action | GE Healthcare will execute a field action in which GE Healthcare Field Engineers will perform an inspection of all suspect MR systems. Any systems lacking any of the 3 laser warning labels will be remediated by applying the missing labels). We expect this field action will be completed by June 30, 2012. 1. Notification of all distributors and purchasers be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. The FDA district office coordinator noted below is to be included in the notifications. 2. Corrections be made at no cost to the |
| Quantity | 4614 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.