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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Oarm Imaging System

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 Class 2 Device Recall Medtronic Oarm Imaging Systemsee related information
Date Initiated by FirmJuly 11, 2012
Date PostedAugust 22, 2012
Recall Status1 Terminated 3 on June 06, 2016
Recall NumberZ-2244-2012
Recall Event ID 62571
510(K)NumberK092564 
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
ProductMedtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Code Information Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact
978-698-6008
Manufacturer Reason
for Recall		A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn.
FDA Determined
Cause 2		Component change control
ActionMedtronic Navigation issued an "Urgent Field Safety Notice" to consignees dated 7/11/12. The problem was described and recommended actions were provided. For each affected O-arm Imaging System, a Medtronic service representative will visit the site and replace the 500VDC relay on the system and test the O-arm Imaging System.
Quantity in Commerce17 units
DistributionWorldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.
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 = OXO
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