FDA recall Z-2396-2023

Philips North America · Class II · device

Product

Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106

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-2396-2023