FDAClass IIMarch 15, 2017

Biograph 16 TruePoint - 3R recall

Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care…

Why was Biograph 16 TruePoint - 3R recalled?

The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.

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?

72444, 72470, 72476, 72480, 72487, 72494, 72515, 72526, 72545

Product
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care…
Recalling firm
Siemens Medical Solutions USA Inc.
Quantity
9 units
Distribution
Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
Recall date
March 15, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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