Philips North America Llc Recall 94508
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
Philips North America Llc Recall 94508 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1857-2024 |
| Event ID | 94508 |
| Event 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 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 10 units |
| Recall Reason | 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 |
| Device Classification | 20240529 |
| Device Code Info | UDI-DI: N/A Serial Numbers: 79010 79008 79006 79009 79011 79003 79004 79002 79012 79005 |
| Center Classification Date | 20240517 |
| Recall Initiation Date | 20240503 |
| Recalling Firm | Philips North America Llc |
| Initial Notification | Letter |
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