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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

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

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.