Device product

MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

Z-2397-2023

June 12, 2023

Class II

Product summary

Firm: Philips North America
Event: Event 92720
Status: Ongoing
Classification: Class II
Quantity: 640 total
Official record key: device-enforcement:Z-2397-2023

Official wording

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

Code information: 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

Distribution pattern: US Nationwide. Global Distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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