GE Healthcare Signa, Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR System, 1.5T Infinity TwinSpeed,
FDA device recall Z-0148-2012 · posted 2012-02-08 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has become aware of missing labels on the alignment lasers.
- Action taken
- 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 purchasers.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- IWE
- Quantity affected
- 4614
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-09-15
- Date posted
- 2012-02-08
- Date terminated
- 2012-06-29
- Location
- Waukesha, WI
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