FDAClass IIJune 22, 2016

Biograph Mct S(20) - 4r recall

BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and…

Why was Biograph Mct S(20) - 4r recalled?

The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.

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 11022

Product
BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and…
Recalling firm
Siemens Medical Solutions USA Inc.
Quantity
1 unit
Distribution
Worldwide Distribution - US Nationwide and the countries of China and Malaysia.
Recall date
June 22, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls