FDA (Devices) recall action 71484
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.
A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
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 40 SOMATOM Emotion 16 CT scanners due to broken or bowed screws in the gantry balance weight assembly.
Siemens Medical Solutions is recalling 40 SOMATOM Emotion 6 CT scanners due to broken or bowed screws securing the gantry balance weight.