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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 4100

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 Class 2 Device Recall Innova 4100see related information
Date Initiated by FirmMarch 06, 2006
Date PostedMay 24, 2006
Recall Status1 Terminated 3 on February 24, 2008
Recall NumberZ-0898-06
Recall Event ID 34758
510(K)NumberK023178 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
ProductGE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital Fluoroscopic Imaging System.
Code Information all devices manufactured before November 2005
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 Commerce291 (213 domestic and 78 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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