FDA Medical Device Recalls (openFDA)
GE Healthcare: GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA The product is used for performing general R&F, radiology, fluoroscopy, interventional and angiography procedures/applications.
- Recall number
- Z-2145-2008
- Recalling firm
- GE Healthcare
- Product
- GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA The product is used for performing general R&F, radiology, fluoroscopy, interventional and angiography procedures/applications.
- Status
- Terminated
- Initiated
- 2008-05-01
- Posted
- 2008-09-19
- Terminated
- 2012-01-07
- Reason
- The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Field Engineers will visit affected customers to make correction.
- Quantity
- 61 (32 US / 29 OUS)
- Distribution
- Within the US to include: AK, CO, IL, IN, LA, MA, MI, MS, NC, NJ, NY, PA, SC,TN, UT, VA, WA, and WI. OUS to include: Australia, Brazil, Canada, Colombia, Korea, Mexico, Philippines, Taiwan, Thailand, and Venezuela.
- Lot, serial or model codes
- serial numbers: 100, 106, 107, 111, 112, 136, 145, 146, 147, 148, 149, 157, 158, 164, 165, 167, 168, 173, 176, 183, 184, 188, 193, 198, 205, 211, 212, 213, 221, 225, 230, 233, 242, 244, 252, 254, 261, 264, 283, 284, 285, 291, 292, 299, 304, 306, 308, 323, 324, 327, 328, 334, 339, 366, 380, 388, 390, 392, 394, 421, and 426.
- 510(k) numbers
- ["K041605"]
- 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