FDA (Devices) recall action 90184
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.
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
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 51 Artis icono biplane angiography systems due to a potential grounding failure that could allow electric shock if someone contacts metallic parts during use.
Siemens Artis icono angiography systems may pose electric shock risk if protective grounding is interrupted. Affected units sold nationwide; users should verify equipment grounding integrity.