FDA Medical Device Recalls (openFDA)
GE Inspection Technologies, LP: GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
- Recall number
- Z-2236-2016
- Recalling firm
- GE Inspection Technologies, LP
- 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.
- Status
- Terminated
- Initiated
- 2016-03-02
- Posted
- 2016-07-23
- Terminated
- 2017-08-07
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE plans to notify its customers with the systems through a TIL. The TIL will inform customers that GE will add lead strips to the inside window frame under the lead glass window of the main cabinet door. GE recommends that it visit each customer site and repair the system by adding lead strips along the window frame of the cabinet door, beneath the lead glass window, within 90 days following FDA's approval of the repair plan.
- Quantity
- 4
- Distribution
- US Distribution to the states of : FL, TN, and TX.
- Lot, serial or model codes
- SN - PA2384
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RCE
- Firm FEI
- 2519904
- Firm city
- Lewistown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28