Z-2397-2023 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
August 16, 2023
Initiation Date
June 12, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
640 total

Product Description

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

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 Pattern

US Nationwide. Global Distribution.

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