Recall Z-2236-2016— GE Inspection Technologies, LP
Class II · Terminated
Class II FDA medical device recall by GE Inspection Technologies, LP, initiated 2016-03-02, terminated 2017-08-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- GE Inspection Technologies, LP
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-02
- Terminated
- 2017-08-07
- Firm location
- Lewistown, PA, United States
Product description
GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.