MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a d...
FDA Device Recall #Z-1854-2024 — Class II — May 3, 2024
Recall Summary
| Recall Number | Z-1854-2024 |
| 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 |
| Quantity | 81 units |
Product Description
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110
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) 782152 N/A (2) 782110 (01)00884838099364(21) Serial Numbers: 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 Serial Number: 30199 30200 30201 30062 30191 30240 30241 30242 30305 30315 30125 30088 30113 30222 30252 30268 30028 30038 30058 30069 30081 30095 30100 30117 30118 30138 30164 30167 30168 30169 30170 30192 30197 30207 30209 30217 30228 30246 30248 30249 30256 30262 30267 30281 30284 30289 30297 30298 30306 30307 30312 30314 30210 30219 30245 30254 30276 30029 30043 30052 30061 30083 30101 30107 30114 30115 30116 30119 30120 30122 30130 30137 30140 30153 30154 30158 30159 30160 30163 30173 30174 30177 30178 30179 30196 30203 30251 30253 30259 30265 30266 30277 30279 30280 30282 30285 30291 30293 30104 30105 30216 30244 30290 30308 30316 30070 30208 30102 30112 30133 30206 30214 30224 30238 30261 30264 30274 30295 30303 30051 30084 30149 30215 30227 30232 30233 30234 30235 30035 30055 30143 30148 30272 30288 30294 8281 30304 30142 30218 30109 30131 30063 30091 30094 30202 30059 30099 30175 30176 30198 30237 30263 30269 30270 30302 30309 8002 8143 8122 8855 8404 30053 30075 30145 30064 30065 30123 30171 30085 30190 30226 30230 30231 30213 30135 30152 30155 30180 30181 30182 30183 30184 30185 30186 30187 30189 30220 30221 30223 30243 30250 30283 30310 30311 30017 30030 30047 30098 10193
Other Recalls from Philips North America Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1316-2026 | Class II | IQon Spectral CT; Product Code (REF): 728332; | Jan 7, 2026 |
| Z-1318-2026 | Class II | Spectral CT 7500 on Rails; Product Code (REF):... | Jan 7, 2026 |
| Z-1317-2026 | Class II | Spectral CT; Product Code (REF): 728333; | Jan 7, 2026 |
| Z-1315-2026 | Class II | Brilliance iCT; Product Code (REF): 728306; | Jan 7, 2026 |
| Z-1033-2026 | Class II | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient M... | Dec 12, 2025 |
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.