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Siemens Medical Solutions USA, Inc recalls Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images
Recalled April 6, 2016 · FDA recall Z-1301-2016 · Siemens Medical Solutions USA
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". · FDA Class II
Units
124 units
Sold at
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.
Description
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".
Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →