FDASeptember 30, 2017device

O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, an...

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

The hazard

During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding metal during the disconnecting/reconnecting process which may result in an electrical short and a shock to the field service technician.

What to do

FDA enforcement status: Terminated

Brands named

medtronic navigation inc littletonmedtronicmedtronic navigation

Recall history

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

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