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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 Recall
Medtronic Oarm Imaging System
see related information
Date Posted August 22, 2012
Recall Status1 Open
Recall Number Z-2244-2012
Recall Event ID 62571
Premarket Notification
510(K) Number
K092564 
Product Classification Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Code OXO
Product Medtronic 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, Massachusetts 01460-2017
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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Medtronic 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 Commerce 17 units
Distribution Worldwide 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 Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OXO and Original Applicant = MEDTRONIC NAVIGATION, INC. (LITTLETON)
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