Home / Recalls / Philips North America Llc / Z-1846-2024

Z-1846-2024 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

Product Description

Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261

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: (1) 781262 (01)00884838068445(21); (2) 781261 (01)00884838068438(21) Serial Numbers: Serial Number 77008 77000 77004 77001 77019 77010 77014 77007 77002 77016 77131 77070 77124 77144 77172 77074 77048 77177 77178 77181 77031 77047 77134 77050 77051 77060 77194 77034 77037 77038 77057 77072 77075 77078 77084 77085 77086 77092 77101 77110 77156 77157 77035 77111 77119 77167 77183 77185 77187 77188 77195 77196 77198 77199 77202 77052 77053 77054 77055 77056 77064 77065 77066 77067 77068 77069 77105 77125 77126 77135 77136 77137 77138 77139 77148 77141 77030 77032 77033 77036 77042 77043 77044 77049 77059 77061 77071 77083 77087 77088 77090 77091 77093 77097 77100 77106 77107 77112 77115 77118 77120 77121 77128 77129 77143 77151 77155 77158 77161 77162 77190 77191 77201 77166 77045 77063 77109 77117 77123 77081 77147 77113 77168 77169 77122 77154 77046 77094 77130 77062 77140 77039 77040 77058 77114 77127 77159 77160 77171 77179 77180 77182 77150 77041 77103 77203

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