Philips North America: Medical Device Recall in 2023 - (Recall #: Z-2397-2023)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2023.
Data Source: FDA.
Product Description:
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Product Classification:
Class II
Date Initiated: June 12, 2023
Date Posted: August 16, 2023
Recall Number: Z-2397-2023
Event ID: 92720
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.
Status: Ongoing
Product Quantity: 640 total
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.
Voluntary or Mandated:
Voluntary: Firm initiated