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Terminated

GE Cabinet X-ray systems

FDA Recall Z-0426-2015 · Posted 2014-12-17

Recalling FirmGE Inspection Technologies, LP
Recall StatusTerminated
Product CodeRCE
Date Initiated2014-11-10
Date Terminated2015-06-29
Product Quantity11

Reason for Recall

GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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