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.
Hazard
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.
What You Should Do
Remedy
GE Field Engineers will visit affected customers to make correction.
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Products
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, interven
- Brand
- GE Healthcare
- UPC
- 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.
Units Affected
61 (32 US / 29 OUS)