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
This recall has been terminated (originally issued September 30, 2006).
- Company
- Ge Healthcare
- Recall Initiated
- November 1, 2006
- Posted
- September 30, 2006
- Terminated
- February 24, 2008
- Recall Number
- Z-1485-06
- Quantity
- 83
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv)
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 / Code Info
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
Root Cause
Other
Action Taken
Correction to devices is being implemented through GEHC Field Modification Instructions.