SOMATOM Force recall
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of…
Why was SOMATOM Force recalled?
The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.
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 Material # 10742326, serial numbers 75550, 75526, 75512, 75567, 75536, 75514, 75563, 75510, 75454, 75540, 75571, 75437, 75500, 75527, 75475, 75535, 75481, 75439, 75450, 75482, 75460, 75493, 75476, 75458, 75528, 75467, 75487, 75478, 75513, 75532, 75555, 75524, 75515, 75559, 75501, 75570, 75576, 75450, 75482, 75528, 75576
- Product
- SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 37 CTsystems
- Distribution
- US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)