Recall Z-0426-2015 ยท RCE Cabinet X-Ray, Industrial
GE Inspection Technologies, LP
GE Cabinet X-ray systems
| Date | Dec 17, 2014 (initiated Nov 10, 2014) |
| Status | Terminated |
| Reason | GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards. |
| Root cause | 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 | 11 |
| Distribution | US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.