CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report
GE Cabinet X-ray systems recalled by GE Inspection Technologies
GE Inspection Technologies is recalling GE Cabinet X-ray systems, distributed in 9 states. The recall was initiated on 10 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0426-2015
- FDA event ID
- 69846
- Recalling firm
- GE Inspection Technologies, Lewistown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2014
- FDA classified
- 17 Dec 2014
- Reported
- 24 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 10 Nov 2014 | Recall initiated by company | |
| 17 Dec 2014 | Classified by FDA | +37 days |
| 24 Dec 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
GE Cabinet X-ray systems
Where it was distributed
US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.
CaliforniaIndianaMichiganNorth CarolinaNew HampshireOregonPennsylvaniaSouth CarolinaWashington
Questions about this recall
Why was it recalled?
GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.
Which lots are affected?
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.
Where was it sold?
US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GE Inspection Technologies
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | v|tome|x L Series non-destructive testing cabinet x-ray systems recalled | Ge Inspection Technologies | Device Malfunction | NY |
| Device | CLASS II | Blade|line Industrial Cabinet X-ray system recalled | GE Inspection Technologies | Processing Deviation | 5 states |
| Device | CLASS II | Phoenix v|tome|x m240 cabinet x-ray systems recalled | GE Inspection Technologies | Device Malfunction | FL, TN, TX |
| Device | CLASS II | Cabinet X-ray system used for industrial quality control recalled | GE Inspection Technologies | Processing Deviation | 24 states |
| Device | CLASS II | GE Optional Laser Centering Device X-ray generator recalled | GE Inspection Technologies | Device Malfunction | 8 states |
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