—#48607

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

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041605
Affected 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

Why it was recalled

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 (FDA determination)

Other

Action the firm took

Correction to devices is being implemented through GEHC Field Modification Instructions.

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2006-11-01
Posted by FDA: 2006-09-30
Terminated: 2008-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48607. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.