FDA (Devices) recall action 73477

Siemens Medical Solutions USA, Inc recalled 8 products on 2016-04-06

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2016-04-06
Critical: 0
Units: 992

Why these products were 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".

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

HighFDA (Devices)··2016-04-06
Siemens CT Systems Recalled for Potential Malfunction Hazard
Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.
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
Category
Distribution
30 states
HighFDA (Devices)··2016-04-06
Siemens CT Systems Recalled for Potential Malfunction Hazard
Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.
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
Category
Distribution
30 states
SevereFDA (Devices)··2016-04-06
Siemens Recalls SOMATOM CT Systems Due to Cardio License Malfunction
Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction in cardio licenses that could hazard patients and personnel.
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
Category
Distribution
30 states
HighFDA (Devices)··2016-04-06
Siemens CT Systems Recalled for Potential Malfunction Hazard
Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.
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
Category
Distribution
30 states
HighFDA (Devices)··2016-04-06
Siemens CT Systems Recalled for Potential Malfunction Hazard
Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.
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
Category
Distribution
30 states
HighFDA (Devices)··2016-04-06
Siemens CT Systems Recalled for Potential Malfunction Hazard
Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.
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
Category
Distribution
30 states
HighFDA (Devices)··2016-04-06
Siemens CT Systems Recalled for Potential Malfunction Hazard
Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.
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
Category
Distribution
30 states
HighFDA (Devices)··2016-04-06
Siemens CT Systems Recalled for Potential Malfunction Hazard
Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.
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
Category
Distribution
30 states