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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012
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Event Detail

Event ID 62571
Product Type Devices
Status Ongoing
Recalling Firm Medtronic Navigation, Inc.
City Littleton
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-11
Initial Firm Notification of
Consignee or Public		 Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414. Class II A fault in a high voltage relay in the 0-arm® Imaging System might cause the relay to overheat and burn. 17 units Z-2244-2012
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