FDAMay 1, 2019device

Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !DOV BI70000027100 BASE...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced

What to do

FDA enforcement status: Terminated

Brands named

medtronic navigation inc littletonmedtronicmedtronic navigation

UPCs

81700000271008170000027120817000002723081700000281008170000028120

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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