FDAClass IIJuly 13, 2016

Medtronic 0-arm Imaging mobile x-ray system recall

Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

Why was Medtronic 0-arm Imaging mobile x-ray system recalled?

It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.

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?

Model No. BI-700-00027 and BT-700-00028

Product
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
Recalling firm
Medtronic Navigation, Inc.-Littleton
Quantity
US - 581
Distribution
Nationwide Distribution
Recall date
July 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls