The Recall Desk
SevereFDA (Devices)·Z-2236-2016·Announced 2016-08-03

GE Phoenix v|tome|x m240 X-Ray Systems Recalled for Radiation Emissions

GE Inspection Technologies is recalling four Phoenix v|tome|x m240 cabinet x-ray systems because radiation emissions exceeded safety limits due to insufficient door shielding.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with significant injury or property damage reports, or structural defects, are rated as Severe (4). While no injuries are reported, the failure of radiation shielding is a significant structural defect.

Plain-English summary

GE Inspection Technologies, LP is recalling four Phoenix v|tome|x m240 cabinet x-ray systems. These microfocus CT systems are used primarily for 3D metrology and analysis. The recall involves units distributed to Florida, Tennessee, and Texas.

The recall was initiated because radiation emissions exceeding 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.

Affected units have the serial number PA2384. Users should contact GE Inspection Technologies, LP for further instructions regarding the recall and repair of the shielding.

The recalled product

Product
GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • SN - PA2384

Distribution

Distributed in 3 states: