FDA (Devices) recall action 75509
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
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 57 SOMATOM Definition Flash CT systems in the US due to a hardware issue that may expose users to rotating or electrical parts.
Siemens Medical Solutions is recalling 57 SOMATOM Definition AS CT systems due to a hardware issue that may expose users to rotating or electrical parts.