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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Innova 3100 / 3100 IQ

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 Class 2 Device Recall GE Healthcare Innova 3100 / 3100 IQsee related information
Date Initiated by FirmMarch 06, 2008
Date PostedMarch 12, 2009
Recall Status1 Terminated 3 on September 04, 2014
Recall NumberZ-1092-2009
Recall Event ID 51159
510(K)NumberK031637 K042053 
Product Classification Solid State X-Ray Imager - Product Code MQB
ProductGE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, 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 82416120006, 4103323100, 82416120005, and 214324INNOVA2
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
ActionOn site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.
Quantity in Commerce4
DistributionWorldwide Distribution -- USA including states of MD, TX, and VA and country of China.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MQB
510(K)s with Product Code = MQB
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