FDAClass IIDecember 24, 2014

Biograph mCT S(64)-4R recall

Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron…

Why was Biograph mCT S(64)-4R recalled?

Possibility for system display freeze during CT interventional procedures.

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: 11021

Product
Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron…
Recalling firm
Siemens Medical Solutions USA Inc.
Quantity
8 units total
Distribution
Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
Recall date
December 24, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls