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U.S. Department of Health and Human Services

Class 2 Device Recall GE Precision RXi

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 Class 2 Recall
GE Precision RXi
see related information
Date Posted September 19, 2008
Recall Status1 Open
Recall Number Z-2145-2008
Recall Event ID 49473
Premarket Notification
510(K) Number
K041605 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
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.
Code Information 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,
Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action GE Field Engineers will visit affected customers to make correction.
Quantity in Commerce 61 (32 US / 29 OUS)
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GENERAL MEDICAL MERATE S.P.A.
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