FDAClass IIMay 29, 2024

Ingenia 1.5T S recall

Ingenia 1.5T S Model Number (REF): 781347

Why was Ingenia 1.5T S 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: (01)00884838068421(21) Serial Numbers: 81003 81050 81051 81090 81111 81010 81027 81028 81030 81035 81063 81106 81093 81105 81116 81007 81004 81006 81009 81011 81016 81017 81018 81019 81020 81023 81024 81031 81037 81041 81055 81056 81057 81060 81062 81064 81070 81074 81078 81112 81115 81122 81146 81147 81153 81156 81158 81013 81044 81040 81047 81059 81167 81170 81171 81008 81108 81148 81133 81164 81001 81086 81079 81118 81138 81139 81140 81151 81175 81184 81069 81061 81065 81098 81085 81091 81092 81032 81043 81129 81131 81149 81155 81162 81165 81172 81180 81084 81087 81088 81094 81095 81100 81127 81132 81174 81157 81176 81071 81052 81067 81039 81038 81179 81185 81117 81173 81154 81025 81097 81152 81015 81029 81033 81034 81042 81046 81048 81049 81058 81072 81080 81103 81113 81123 81128 81137 81045 81075 81076 81077 81096 81114 81124 81126 81145 81159 81178

Product
Ingenia 1.5T S Model Number (REF): 781347
Recalling firm
Philips North America Llc
Quantity
139 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.
Recall date
May 29, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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