FDAClass IIMarch 16, 2016

Medtronic 0-arm 02 Imaging System recall

Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and…

Why was Medtronic 0-arm 02 Imaging System recalled?

Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Number: C0936

Product
Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and…
Recalling firm
Medtronic Navigation, Inc.
Quantity
1 unit
Distribution
Worldwide Distribution to Austria only.
Recall date
March 16, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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