Recall Z-2320-2015 ยท RER Alignment Laser Product
GE Inspection Technologies, LP
GE Optional Laser Centering Device X-ray generator.
| Date | Aug 13, 2015 (initiated Nov 10, 2014) |
| Status | Terminated |
| Reason | GE has identified a potential failure to comply with 21 C.F.R. 1040.10 and 21 C.F.R. 1010.2 for the alignment laser centering device. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE's Planned Action for repair: 1. Replacement compliant laser centering devices will be shipped to purchasers, with prepaid shipping envelopes for purchasers to return the noncompliant units to GE. 2.All mailings will be made at no cost to the purchaser; and 3.The corrections will be completed by November 1, 2015 Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notific |
| Quantity | 25 |
| Distribution | US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.