CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report
Phoenix v|tome|x m240 cabinet x-ray systems recalled
GE Inspection Technologies is recalling Phoenix v|tome|x m240 cabinet x-ray systems, distributed in Florida, Tennessee, Texas. The recall was initiated on 2 Mar 2016 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-2236-2016
- FDA event ID
- 74554
- Recalling firm
- GE Inspection Technologies, Lewistown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Mar 2016
- FDA classified
- 22 Jul 2016
- Reported
- 3 Aug 2016
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 2 Mar 2016 | Recall initiated by company | |
| 22 Jul 2016 | Classified by FDA | +142 days |
| 3 Aug 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.
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 Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
Where it was distributed
US Distribution to the states of : FL, TN, and TX.
Questions about this recall
Why was it recalled?
Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.
Which lots are affected?
SN - PA2384
Where was it sold?
US Distribution to the states of : FL, TN, and TX.
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.
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|---|---|---|---|---|---|
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| Device | CLASS II | Blade|line Industrial Cabinet X-ray system recalled | GE Inspection Technologies | Processing Deviation | 5 states |
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