FDA recall Z-2395-2023

Philips North America · Class II · device

Product

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)

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.

Key facts

Status
Ongoing
Initiation date
2023-06-12
Report date
2023-08-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2395-2023