FDAClass IIMarch 15, 2017

Biograph 6 TruePoint recall

Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care…

Why was Biograph 6 TruePoint 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?

1010, 1015, 1034, 1044, 45503, 45537

Product
Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care…
Recalling firm
Siemens Medical Solutions USA Inc.
Quantity
6 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)
Open FDA enforcement record Latest recalls