Z-2397-2023 Class II Ongoing
FDA device recall Z-2397-2023 was initiated by Philips North America on June 12, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 640 total.
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