Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device... — FDA record Z-1856-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 3, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
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
Classification
Class II
Recalling firm
Philips North America Llc
Quantity
81 units
Agency-reported status
Ongoing
Source record identifier
Z-1856-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityUDI-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

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
May 29, 2024
Recall initiation date
May 3, 2024
Center classification date
May 17, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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