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U.S. Department of Health and Human Services

Class 2 Device Recall xcube and VTOMEX

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  Class 2 Device Recall xcube and VTOMEX see related information
Date Initiated by Firm November 10, 2014
Date Posted December 17, 2014
Recall Status1 Terminated 3 on June 29, 2015
Recall Number Z-0426-2015
Recall Event ID 69846
Product Classification Cabinet x-ray, industrial - Product Code RCE
Product GE Cabinet X-ray systems
Code Information XXL cabinet x-ray systems, serial numbers A586590 and A586780; xlcube compact cabinet x-ray systems, serial numbers A583730, A586430, and A586460; a VTOMEX C450 cabinet x-ray system, serial number VTXO1JOOO2-2245 14; VTOMEX L300 cabinet x-ray systems, serial numbers VTX01lF007-208813, VTX01F007-196312 and VTXO1FOO07-1946 12; and VTOMEX L450 cabinet x-ray systems, serial numbers VTXO1K0001-184711 and PX_10E000-179013.
Recalling Firm/
Manufacturer		 GE Inspection Technologies, LP
50 Industrial Park Rd
Lewistown PA 17044-9312
For Additional Information Contact Customer Support
717-447-1278
Manufacturer Reason
for Recall		 GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE intends to notify its customers of the affected cabinet x-ray systems regarding the warning signs' potential failure to comply with 21 C.F.R. ¿ 1020.40(c)(7)(v) through a Technical Information Letter. The notification will inform customers that GE plans to replace the current warning signs with warning signs that comply with the requirements set forth in 21 C.F.R. ¿ 1020.40(c)(7)(v). GE will recommend in its notification that it replace the warning sign at the customer's next service interval, but no later than December 31, 2014. For further questions please call (717) 447-1278.
Quantity in Commerce 11
Distribution US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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