Z-1856-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

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
81 units

Product Description

Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474

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: Serial Number 79113 79118 79127 79157 79122 79147 79105 79150 79152 79183 79192 79102 79108 79112 79115 79116 79153 79156 79162 79163 79164 79168 79188 79189 79100 79126 79179 79143 79159 79104 79132 79160 79182 79165 79107 79158 79175 79136 79138 79139 79184 79176 79180 79171 79172 79111 79125 79134 79135 79148 79177 79181 79173 79187 79190 79133 79110 79101 79117 79166 79124 79123 79130 79174 79178 79151 79114 79103 79106 79121 79128 79129 79137 79140 79155 79161 79167 79169 79170 79185