FDA Medical Device Recalls (openFDA)
General Electric Med Systems LLC: GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator; angulating table with x-ray Tube, collimator and image intensifier; wall stand; Overhead tube suspension; operator console and digital archive system.
- Recall number
- Z-1304-06
- Recalling firm
- General Electric Med Systems LLC
- Product
- GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator; angulating table with x-ray Tube, collimator and image intensifier; wall stand; Overhead tube suspension; operator console and digital archive system.
- Status
- Terminated
- Initiated
- 2006-05-15
- Posted
- 2006-09-22
- Terminated
- 2007-05-25
- Reason
- Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept the entire cross section of the useful beam
- Root cause
- Other
- Action
- An Important Notice for Precision 500D, dated 11/24/2005 was hand delivered to all customers beginning 05/15/06, by GE field service engineers at the time they were to perform the correction to the device.
- Quantity
- 1,289
- Distribution
- Worldwide, including USA, Puerto Rico, Canada, France, Germany, Indonesia, Italy, Japan, Jordan, Kuwait, Macedonia, Panama, Russia, Saudi Arabia, Singapore, and United Kingdom.
- Lot, serial or model codes
- All serial numbers affected
- 510(k) numbers
- ["K011624"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- 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