FDAFDA · Food and drugs·Recall number Z-0607-2017
SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended 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 angles or spiral planes* taken at different angles
Published November 23, 2016 · Recall initiated: November 2, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide distribution to MI, NY, CA, KY, ND, and NE.
- Lot
- Model Number: 1059000 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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