FDA Medical Device Recalls (openFDA)
GE Healthcare: GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 80 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32cm or 40cm image intensifier. GE Healthcare
- Recall number
- Z-1485-06
- Recalling firm
- GE Healthcare
- Product
- GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 80 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32cm or 40cm image intensifier. GE Healthcare
- Status
- Terminated
- Initiated
- 2006-11-01
- Posted
- 2006-09-30
- Terminated
- 2008-02-24
- Reason
- Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv)
- Root cause
- Other
- Action
- Correction to devices is being implemented through GEHC Field Modification Instructions.
- Quantity
- 83
- Distribution
- within US: CO, IL, LA, MA, MI, NC, PA, SC,TN, VA. OUS to include: Austrailia, Belgium, Burkina Faso, Brazil, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Italy, Republic of Korea, Lebanon, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Taiwan, Republic of China, United Kingdom
- Lot, serial or model codes
- 198109, 229088, 241096, 117130, 156120, 116119, 127130, 174114, 193102, 183100, 252092, 261088, 148113, 149126, 184116, 165110, 188101, 164106, 157123, 23775004, 244092, 113127, 127114, 185099, 170109, 179118, 257083, 224091, 162108, 108130, 199100, 202104, 204100, 186106, 237092, 262080, 166119, 120116, 245094, 260086, 231092, 109129, 114127, 135125, 104125, 105126, 124130, 001000, 133131, 118128, 121135, 205104, 243091, 115126, 217100, 134128, 219096, 218096, 2338037, 122130, 110129, 140132, 23949001, 172112, 130130, 112131, 145124, 146119, 292081, 233089, 23778003, 211100, 173106, 283093, 213098, 230093, 107127, 225100, 291074, 176119, 264095, 144117, 255085
- 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
- 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