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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Innova 4100 / 4100 IQ

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  Class 2 Device Recall GE Healthcare Innova 4100 / 4100 IQ see related information
Date Initiated by Firm March 06, 2008
Date Posted March 12, 2009
Recall Status1 Terminated 3 on September 04, 2014
Recall Number Z-1093-2009
Recall Event ID 51159
510(K)Number K023178  K042053  
Product Classification Solid State X-Ray Imager - Product Code MQB
Product Innova 4100 / 4100 IQ, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector).

Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications.
Code Information 757398INNOVA
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall		 GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.
FDA Determined
Cause 2		 Software design
Action On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.
Quantity in Commerce 1
Distribution Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.
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 = MQB and Original Applicant = GE MEDICAL SYSTEMS, INC.
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