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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
GE Healthcare
Lot Codes / Batch Numbers
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
Products Sold
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
GE Healthcare is recalling GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F due to Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv)
Recommended Action
Per FDA guidance
Correction to devices is being implemented through GEHC Field Modification Instructions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, IL, LA, MA, MI, NC, PA, SC, TN, VA
Page updated: Jan 10, 2026