Z-2777-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2017
- Initiation Date
- June 28, 2017
- Termination Date
- February 6, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 13 units distributed in the US
Product Description
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
Reason for Recall
GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR ¿ 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.
Distribution Pattern
US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore
Code Information
Serial No. TM 201317 TM 201312 TM 201323 TM 201331 TM 201401 TM 201329 TM 201404 TM 201413 TM 201414 TM 201415 TM 201424 TM 201425 158017R1