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U.S. Department of Health and Human Services

Class 2 Device Recall GE Precision MPi

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  Class 2 Device Recall GE Precision MPi see related information
Date Initiated by Firm May 01, 2008
Date Posting Updated September 19, 2008
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-2144-2008
Recall Event ID 49471
510(K)Number K033486  
Product Classification Multi-purpose X-ray system - Product Code JAA
Product GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA
The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.
Code Information to follow
Recalling Firm/
GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
Manufacturer Reason
for Recall
The Precision MPi 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
Action GE Field Engineers visited affected customers to make the correction.
Quantity in Commerce 54 (24 US / 30 OUS)
Distribution Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JAA and Original Applicant = NRT-NORDISK RONTGEN TEKNIK A/S