FDAClass IIMarch 18, 2015

SIEMENS SOMATOM Force with software version VA50A and recall

SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of…

Why was SIEMENS SOMATOM Force with software version VA50A and recalled?

Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG handling with visual feedback of correct placement of ECG leads and contact quality, and other safety related issues.

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?

Model number: 10742326, with serial numbers: 75454, 75464, 75437, 75475, 75481, 75439, 75450, 75460, 75476, 75458, 75467, 75478.

Product
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
12
Distribution
US Nationwide Distribution in the states of PA, MA, MN, NY, SC, MD, NY, IL, OH, TX and KY.
Recall date
March 18, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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