FDA recall Z-2399-2023

Philips North America · Class II · device

Product

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

Reason for recall

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock 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-2399-2023