| Class 2 Device Recall xcube and VTOMEX | |
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 |
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Product Classification |
Cabinet x-ray, industrial - Product Code RCE
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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
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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 |
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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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