GE Precision RXi Digital remote X-Ray Imaging R&F System…

Date posted by the FDA

Sept. 19, 2008

Status

Terminated

Filed by

GE Healthcare

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.

Reason

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.

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.

Quantity

61 (32 US / 29 OUS)

Codes and lots

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.

Recall started

May 1, 2008

Device type

System, X-Ray, Fluoroscopic, Image-Intensified

Root cause (FDA)

Radiation Control for Health and Safety Act

What the company told customers

GE Field Engineers will visit affected customers to make correction.

Recall number

Z-2145-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2145-2008. The agency record governs; check it and the company before acting.