| Class 2 Device Recall GE Precision MPi | |
Date Initiated by Firm | May 01, 2008 |
Date Posted | 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
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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/ Manufacturer |
GE Healthcare 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | 262-544-3894 |
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 |
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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
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