FDA (Devices) recall action 79665
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
A potential risk of unnecessary radiation exposure due to a software issue
The agency’s own wording, quoted from the enforcement report.
Siemens Medical Solutions is recalling SOMATOM Perspective CT scanners due to a software issue that may cause unnecessary radiation exposure.
Siemens Medical Solutions USA is recalling SOMATOM Perspective 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.
Siemens Medical Solutions is recalling SOMATOM Spirit CT scanners due to a software issue that may cause unnecessary radiation exposure.
Siemens Medical Solutions is recalling SOMATOM Emotion 6 CT scanners due to a software issue that may cause unnecessary radiation exposure.
Siemens Medical Solutions is recalling SOMATOM Scope devices due to a software issue that may cause unnecessary radiation exposure.
Siemens is recalling SOMATOM Scope Power units due to a software issue that may cause unnecessary radiation exposure.
Siemens Medical Solutions is recalling SOMATOM Emotion 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.