Philips North America: MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

Hazard

The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

Details from the source

Reason for recall: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. Distribution: US Nationwide. Global Distribution. Quantity: 640 total Lot/code info: Product Number: 782120: UDI-DI: 00884838104112; Serial Numbers: 65041 65031 65030 65025 65023 65019 65013 65009 65008 65007 65006 65005 65004 65003 65002 65000 65020 65012 65034 65001; Product Number 782130: UDI-DI: 00884838104402; Serial Numbers: 45301 45298 45007 45297 45557

UPC codes

00884838104112, 00884838104402

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.