FDA (Devices) recall action 92720
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
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.
Philips Ingenia Elition X MR systems can have their smoke detection safety interlock bypassed by power cycling the equipment. This vulnerability could allow unsafe operation during hazardous conditions.
Philips MR 7700 MRI systems can have their smoke detector interlock safety mechanism bypassed when power cycled after smoke detection, allowing continued operation despite potential fire hazards.
Philips Ingenia Elition S MR systems can be circumvented by power cycling to bypass the smoke detection safety interlock that locks after smoke is detected. This could allow continued operation despite fire hazards.