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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 2000 and Innova 2000 S; and Innova 2000 and Innova 2000S mobile version

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 Class 2 Device Recall Innova 2000 and Innova 2000 S; and Innova 2000 and Innova 2000S mobile versionsee related information
Date Initiated by FirmMarch 06, 2006
Date PostedMay 24, 2006
Recall Status1 Terminated 3 on February 24, 2008
Recall NumberZ-0896-06
Recall Event ID 34758
510(K)NumberK022322 K024200 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
ProductGE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System.
Code Information all serial numbers
FEI Number 2126677
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall		Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.
FDA Determined
Cause 2		Other
ActionGEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033.
Quantity in Commerce856 (534 domestic and 322 OUS)
DistributionNationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Indonesia, Iraq, Ireland, Israel, India, Iran, Italy, Jordan, Japan, Republic of Korea, Lebanon, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic of China, Thailand, Tunisia, Turkey, United Kingdom, Venezuela
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
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