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Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for u...

FDA Device Recall #Z-1846-2024 — Class II — May 3, 2024

Recall Summary

Recall Number Z-1846-2024
Classification Class II — Moderate risk
Date Initiated May 3, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips North America Llc
Location Cambridge, MA
Product Type Devices

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.

Lot / 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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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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