Z-2320-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2015
- Initiation Date
- November 10, 2014
- Termination Date
- February 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25
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.
Distribution Pattern
US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.
Code Information
Model No. 025.03.00A