Recall Z-2320-2015— GE Inspection Technologies, LP
Class II · Terminated
Class II FDA medical device recall by GE Inspection Technologies, LP, initiated 2014-11-10, terminated 2017-02-01. FDA's recall record names no specific 510(k) clearance for this event. Product: GE Optional Laser Centering Device X-ray generator.. 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..
- Recalling firm
- GE Inspection Technologies, LP
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-10
- Terminated
- 2017-02-01
- Firm location
- Lewistown, PA, United States
Product description
GE Optional Laser Centering Device X-ray generator.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.