FDA Medical Device Recalls (openFDA)
GE Inspection Technologies, LP: GE Cabinet X-ray systems
- Recall number
- Z-0426-2015
- Recalling firm
- GE Inspection Technologies, LP
- Product
- GE Cabinet X-ray systems
- Status
- Terminated
- Initiated
- 2014-11-10
- Posted
- 2014-12-17
- Terminated
- 2015-06-29
- Reason
- GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE intends to notify its customers of the affected cabinet x-ray systems regarding the warning signs' potential failure to comply with 21 C.F.R. 1020.40(c)(7)(v) through a Technical Information Letter. The notification will inform customers that GE plans to replace the current warning signs with warning signs that comply with the requirements set forth in 21 C.F.R. 1020.40(c)(7)(v). GE will recommend in its notification that it replace the warning sign at the customer's next service interval, but no later than December 31, 2014. For further questions please call (717) 447-1278.
- Quantity
- 11
- Distribution
- US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.
- Lot, serial or model codes
- 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.
- 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