—#73521

Product

GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA The product is used for performing general R&F, radiology, fluoroscopy, interventional and angiography procedures/applications.

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: serial numbers: 100, 106, 107, 111, 112, 136, 145, 146, 147, 148, 149, 157, 158, 164, 165, 167, 168, 173, 176, 183, 184, 188, 193, 198, 205, 211, 212, 213, 221, 225, 230, 233, 242, 244, 252, 254, 261, 264, 283, 284, 285, 291, 292, 299, 304, 306, 308, 323, 324, 327, 328, 334, 339, 366, 380, 388, 390, 392, 394, 421, and 426.

Why it was recalled

The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE Field Engineers will visit affected customers to make correction.

Recalling firm

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

Distribution

Distribution pattern: Within the US to include: AK, CO, IL, IN, LA, MA, MI, MS, NC, NJ, NY, PA, SC,TN, UT, VA, WA, and WI. OUS to include: Australia, Brazil, Canada, Colombia, Korea, Mexico, Philippines, Taiwan, Thailand, and Venezuela.

Timeline

Recall initiated: 2008-05-01
Posted by FDA: 2008-09-19
Terminated: 2012-01-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73521. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.