FDA Medical Device Recalls (openFDA)
GE Inspection Technologies, LP: GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
- Recall number
- Z-2777-2017
- Recalling firm
- GE Inspection Technologies, LP
- Product
- GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
- Status
- Terminated
- Initiated
- 2017-06-28
- Posted
- not on file
- Terminated
- 2020-02-06
- Reason
- GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Inspection Technologies will bring the defect into compliance: 1. Four panels of sheet metal/lead/sheet metal construction (6 mm lead thickness) will be permanently mounted using an industrial epoxy to the inside floor of the cabinet to prevent emissions from exceeding the limit in the performance standard. A radiation emission measurement will be made following the repairs of each system to assure the issue was corrected. 2. GE will notify affected customers within 5 days of GEs receipt of this approval letter. 3. The notification will recommend that customers allow GE to visit the site and install the new shielding within 120 days following GEs receipt of this letter. 4.The text of the notification to customers will include the required statement that confirms that GE will, without charge, bring the affected cabinet x-ray systems into compliance with the performance standard. For further questions, please call (717) 447-1278.
- Quantity
- 13 units distributed in the US
- Distribution
- US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore
- Lot, serial or model codes
- Serial No. TM 201317 TM 201312 TM 201323 TM 201331 TM 201401 TM 201329 TM 201404 TM 201413 TM 201414 TM 201415 TM 201424 TM 201425 158017R1
- 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