FDA Medical Device Recalls (openFDA)
GE Inspection Technologies, LP: Phoenix x/ray v/tome/x series. Phoenix x|ray v|tome|x series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.
- Recall number
- Z-1827-2011
- Recalling firm
- GE Inspection Technologies, LP
- Product
- Phoenix x/ray v/tome/x series. Phoenix x|ray v|tome|x series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.
- Status
- Terminated
- Initiated
- 2009-03-16
- Posted
- 2011-04-06
- Terminated
- 2017-04-17
- Reason
- Some of the systems do not have a safety interlock on the service access panel. Although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. Also, some systems lack proper placement of a caution label and others do not have this label affixed. Two of the systems also lack the sign indicating the meaning of the warning signals.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- The firm has completed all of the following necessary actions and no further actions have been indicated: A Field Service Memo was issued to customers. It described the affected product and described the issue. GE Sensing and Inspection provided and installed retrofit kits, and the systems in question were tested by qualified Field Service Engineers at no charge to customers. GE asked customers to post the notification letter on the affected equipment until retrofit was completed. Questions were to be directed to the GE Service Center at 800-766-6062.
- Quantity
- 118 units total
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- All affected units.
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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