Siemens Medical Solutions USA, Inc recalls Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images…

Recall date

February 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1303-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

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.

Why it was recalled

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".

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.