FDA (Devices) recall action 79295
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
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 is recalling 238 SOMATOM Definition Flash CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure.
Siemens Medical Solutions is recalling 1,385 SOMATOM Definition AS CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure.
Siemens is recalling 91 SOMATOM Force CT scanners due to a software issue that may cause unnecessary radiation exposure.
Siemens Medical Solutions is recalling 134 SOMATOM Definition Edge CT scanners due to a software issue that may cause unnecessary radiation exposure.