FDAFDA · Food and drugs·Recall number Z-1301-2016
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems 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 April 6, 2016 · Recall initiated: February 15, 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 initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro".
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.
- Lot
- Model Number: SOMATOM Emotion 16 - 7734713
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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