Z-1863-2024 Class II Ongoing
FDA device recall Z-1863-2024 was initiated by Philips North America Llc on May 3, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- May 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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
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
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.
Code Information
UDI-DI: (01)00884838099746(21)42194 Serial Number: 42194
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1863-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026