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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 Device Recall GE Precision RXisee related information
Date Initiated by FirmMay 01, 2008
Date PostedSeptember 19, 2008
Recall Status1 Terminated 3 on January 07, 2012
Recall NumberZ-2145-2008
Recall Event ID 49473
510(K)NumberK041605 
Product Classification Fluoroscopic X-ray system - Product Code JAA
ProductGE 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.
FEI Number 2126677
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
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
ActionGE Field Engineers will visit affected customers to make correction.
Quantity in Commerce61 (32 US / 29 OUS)
DistributionWithin 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAA
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