FDAClass IIJune 27, 2012

Medtronic 0-arm Imaging System with Software Version recall: Software Issue

Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a…

Why was Medtronic 0-arm Imaging System with Software Version recalled?

Software Version 3.1.1 does not meet navigational accuracy.

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 Numbers: 125, 156, 234R.

Product
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a…
Recalling firm
Medtronic Navigation, Inc.
Quantity
3 units
Distribution
Nationwide Distribution including the states of CO, IN, and MN.
Recall date
June 27, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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