FDA Medical Device Recalls (openFDA)
GE Inspection Technologies, LP: GE Optional Laser Centering Device X-ray generator.
- Recall number
- Z-2320-2015
- Recalling firm
- GE Inspection Technologies, LP
- Product
- GE Optional Laser Centering Device X-ray generator.
- Status
- Terminated
- Initiated
- 2014-11-10
- Posted
- 2015-08-13
- Terminated
- 2017-02-01
- Reason
- GE has identified a potential failure to comply with 21 C.F.R. 1040.10 and 21 C.F.R. 1010.2 for the alignment laser centering device.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE's Planned Action for repair: 1. Replacement compliant laser centering devices will be shipped to purchasers, with prepaid shipping envelopes for purchasers to return the noncompliant units to GE. 2.All mailings will be made at no cost to the purchaser; and 3.The corrections will be completed by November 1, 2015 Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification. For further questions please call (717) 447-1278.
- Quantity
- 25
- Distribution
- US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.
- Lot, serial or model codes
- Model No. 025.03.00A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RER
- 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