FDA (Devices) recall action 97050
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 resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
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 UROSKOP Omnia Max medical devices due to a resistor in the frequency inverter that may overheat and ignite the plastic housing. Twenty-five units distributed nationwide are affected.
Siemens is recalling 95 units of the UROSKOP Omnia X-ray system nationwide due to a resistor in the frequency inverter that may overheat and potentially ignite the plastic housing.