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Class 2 Device Recall GE Precision MPi |
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Date Initiated by Firm |
May 01, 2008 |
Date Posted |
September 19, 2008 |
Recall Status1 |
Terminated 3 on December 17, 2011 |
Recall Number |
Z-2142-2008 |
Recall Event ID |
49471 |
510(K)Number |
K033486
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Product Classification |
Multi-purpose X-ray system - Product Code JAA
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Product |
GE Precision MPi, model 5126893. 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 |
serial numbers: 507001, 507002, 507003, 507004, 507005, 507006, 507007, 507008, 510001, 510002, 510003, 510004, 510005, 510006, 510007, 510008, 510009, 510010, 513001, 513002, 513004, 513005, 513006, 513007, 513008, 513009, 513010, 513011, 518002, 518003, 518004, 518005, 518006, 518007, 518008, 518009, 518010, 518011, 518012, 518013, 518014, 518015, 518016, 518017, 518018, 518019, 518020, 522001, 522002, 522003, 522004, 522005, 522006, and 522008. |
Recalling Firm/ Manufacturer |
GE Healthcare 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact |
262-544-3894
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = JAA and Original Applicant = NRT-NORDISK RONTGEN TEKNIK A/S
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