Recall Z-2777-2017— GE Inspection Technologies, LP
Class II · Terminated
Class II FDA medical device recall by GE Inspection Technologies, LP, initiated 2017-06-28, terminated 2020-02-06. FDA's recall record names no specific 510(k) clearance for this event. Product: GE Inspection Technologies Blade|line Industrial Cabinet X-ray system. 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..
- Recalling firm
- GE Inspection Technologies, LP
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-28
- Terminated
- 2020-02-06
- Firm location
- Lewistown, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.