FDAFDA · Food and drugs·Recall number Z-0426-2015
GE Cabinet X-ray systems
Published December 24, 2014 · Recall initiated: November 10, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Inspection Technologies, LP
- Distributor
- US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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