GE Optional Laser Centering Device X-ray generator.
FDA device recall Z-2320-2015 · posted 2015-08-13 · Terminated
Recall details
- Recalling firm
- GE Inspection Technologies, LP
- Reason for recall
- 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.
- Action taken
- 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 notification. For further questions please call (717) 447-1278.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- RER
- Quantity affected
- 25
- Distribution
- US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.
- Date initiated
- 2014-11-10
- Date posted
- 2015-08-13
- Date terminated
- 2017-02-01
- Location
- Lewistown, PA
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