Reported May 4, 2016 · Terminated
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
- Lot codes and dates
SOMATOM Force Material # 10742326serial numbers 7555075526755127556775536755147556375510754547554075571754377550075527754757553575481754397545075482754607549375476754587552875467754877547875513755327555575524755157555975501755707557675450754827552875576
- Amount recalled
- 37 CTsystems
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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