Z-1857-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- May 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
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: N/A Serial Numbers: 79010 79008 79006 79009 79011 79003 79004 79002 79012 79005