Z-1485-06

GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F system...

Name: Z-1485-06 GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F system...
Creator: GE Healthcare
Published: 2006-11-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-11-01 / Terminated

FDA source

GE Healthcare began a recall of 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... on 2006-11-01. The reason FDA records is "Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1485-06
Status: Terminated
Initiated: 2006-11-01
Posted: 2006-09-30
Terminated: 2008-02-24
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
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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)
FDA root cause: Other
Action: Correction to devices is being implemented through GEHC Field Modification Instructions.
Quantity in commerce: 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
Product codes and lots: 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

Product code JAA

K041605Class IIPrecision Rxi Analog X-Ray SystemGeneral Medical Merate S.P.A / cleared 2004-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)