Device Recall Bladeline Cabinet Xray system 의 리콜

Recall

77756

Class 2

Z-2777-2017

2017-06-28

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157833

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.

GE Inspection Technologies will bring the defect into compliance: 1. Four panels of sheet metal/lead/sheet metal construction (6 mm lead thickness) will be permanently mounted using an industrial epoxy to the inside floor of the cabinet to prevent emissions from exceeding the limit in the performance standard. A radiation emission measurement will be made following the repairs of each system to assure the issue was corrected. 2. GE will notify affected customers within 5 days of GEs receipt of this approval letter. 3. The notification will recommend that customers allow GE to visit the site and install the new shielding within 120 days following GEs receipt of this letter. 4.The text of the notification to customers will include the required statement that confirms that GE will, without charge, bring the affected cabinet x-ray systems into compliance with the performance standard. For further questions, please call (717) 447-1278.