Philips North America Llc: Medical Device Recall in 2024 - (Recall #: Z-1863-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118

Product Classification:

Class II

Date Initiated: May 3, 2024

Date Posted: May 29, 2024

Recall Number: Z-1863-2024

Event ID: 94508

Reason for Recall:

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Status: Ongoing

Product Quantity: 1 unit

Code Information:

UDI-DI: (01)00884838099746(21)42194 Serial Number: 42194

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated