FDA (Devices) recall action 79428
The FDA (Devices) publishes a recall like this one as 15 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 15 pages.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
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.
Siemens Medical Solutions is recalling SOMATOM Spirit CT scanners because the CARE Dose4D algorithm may calculate incorrect tube current for head scans, potentially leading to unnecessary radiation exposure.
Siemens Medical Solutions is recalling 1,301 SOMATOM Perspective CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary exposure.
Siemens is recalling 1,301 SOMATOM Emotion 6 CT scanners because the CARE Dose4D algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary exposure.
Siemens Medical Solutions is recalling 1,301 SOMATOM Sensation 64 CT scanners because the CARE Dose4D algorithm may calculate incorrect tube current for head scans, potentially leading to unnecessary radiation exposure.
Siemens Medical Solutions is recalling SOMATOM Scope Power CT scanners due to potential incorrect radiation dose calculations for head scans.
Siemens is recalling 1,301 SOMATOM Perspective 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.
Siemens is recalling 1,301 SOMATOM Emotion CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.
Siemens Medical Solutions is recalling 1,301 SOMATOM Sensation 10 CT scanners due to a software error that may cause unnecessary radiation exposure during head scans.
Siemens is recalling 1,301 SOMATOM Sensation Open CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary exposure.
Siemens Medical Solutions is recalling 1,301 SOMATOM Emotion 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.
Siemens is recalling SOMATOM Emotion Duo CT scanners because a software algorithm may calculate incorrect radiation doses for head scans, potentially exposing patients to unnecessary radiation.
Siemens is recalling 1,301 SOMATOM Sensation 16 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.
Siemens Medical Solutions is recalling SOMATOM Scope CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially leading to unnecessary radiation exposure.
Siemens is recalling 1,301 SOMATOM Sensation 40 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.
Siemens is recalling 1,301 SOMATOM Sensation Cardiac CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.