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Recall Observatory FDA recall evidence

Device product

GE Inspection Technologies Blade|line Industrial Cabinet X-ray system

Z-2777-2017

June 28, 2017

Class II

Product summary

Firm
GE Inspection Technologies, LP
Event
Event 77756
Status
Terminated
Classification
Class II
Quantity
13 units distributed in the US
Official record key
device-enforcement:Z-2777-2017

Official wording

Reason: 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.

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

Distribution pattern: US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.