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SIEMENS SOMATOM Force with software version VA50A and /or… recallZ-1267-2015 · Siemens Medical Solutions USA, Inc · initiated Feb 6, 2015

Class II Terminated All recalls posted in March 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Software design

What the company is doing

Siemens sent a Customer Advisory Notice dated February 6, 2015, to all customers via USPS Certified Mail. The notice identified the affected product, problem and actions to be taken.

Recall details

Recall number
Z-1267-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 6, 2015
Posted by the FDA
Mar 12, 2015
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
12
Product code
JAK
FDA submissions
K133589
Distribution
US Nationwide Distribution in the states of PA, MA, MN, NY, SC, MD, NY, IL, OH, TX and KY.

Product description

SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K133589 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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