FDA (Devices) recall action 80476
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.
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
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 six AXIOM Artis angiography systems in the US due to a defective sealing that could allow coolant to leak into electrical parts.
Siemens is recalling Artis zee angiography systems with specific Laird cooling units due to defective seals that may allow coolant to leak into electrical parts, potentially causing sudden system shutdowns.