FDAClass IIAugust 12, 2015

Biograph mCT Flow Edge-4R recall

Biograph mCT Flow Edge-4R, Model Number 10528955

Why was Biograph mCT Flow Edge-4R recalled?

Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

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: 11002, 11005, 1008

Product
Biograph mCT Flow Edge-4R, Model Number 10528955
Recalling firm
Siemens Medical Solutions USA Inc.
Quantity
3 units
Distribution
Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.
Recall date
August 12, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls