MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
Reported: May 29, 2024 Initiated: May 3, 2024 #Z-1857-2024
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
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 10 units
- 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.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483. Recalled by Philips North America Llc. Units affected: 10 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2024. Severity: Moderate. Recall number: Z-1857-2024.
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