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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare innova 3131IQ

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  Class 2 Device Recall GE Healthcare innova 3131IQ see related information
Date Initiated by Firm December 20, 2011
Date Posted October 17, 2012
Recall Status1 Terminated 3 on September 18, 2013
Recall Number Z-0115-2013
Recall Event ID 63027
Product Classification System, x-ray, angiographic - Product Code IZI
Product GE Healthcare innova 3131-IQ Mobile X-ray system.

The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
Code Information Model number - 5892935G052G
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. A GE Healthcare Service Representative will replace the collimator to address the issue. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call 262-513-4122.
Quantity in Commerce 199 installed in the US
Distribution Nationwide distribution
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.
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