FDAClass IIJanuary 20, 2021

SOMATOM Force recall

SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

Why was SOMATOM Force recalled?

System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

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?

SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000) Siemens SOMATOM CT scanner systems with software syngo.CT VB20A_SP2.

Product
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
3044
Distribution
US Nationwide
Recall date
January 20, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls