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SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Syst...

FDA Device Recall #Z-1862-2024 — Class II — May 3, 2024

Recall Summary

Recall Number Z-1862-2024
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 200 units

Product Description

SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270

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) 782129 (01)00884838105805(21); (2) 782113 (01)00884838098909(21); (3) 781270 (01)00884838095083(21) Serial Numbers: Serial Number 17536 17546 17212 17508 23011 35056 17434 17302 17429 24108 17006 17378 17386 17533 17590 35052 17204 17264 17292 17339 17398 17415 17416 17436 17440 17447 17544 23030 24055 35087 17473 17283 17247 17265 17268 17286 17353 17367 17389 17425 17509 17517 17572 17580 24022 24036 24098 35020 35078 23002 24018 17514 17524 23026 24087 24095 17260 17222 17242 17245 17250 17269 17299 17308 17309 17342 17357 17388 17399 17464 17468 17493 17499 17556 17559 17564 17565 17569 17589 17594 24006 24012 24023 24047 24109 24110 24111 24124 24134 24143 35027 35046 35048 38015 17305 24117 17266 17471 17428 38131 17194 17246 23036 17610 17550 24145 34250 17237 17352 17321 17344 17495 17570 17615 24020 24090 17274 35047 17326 17466 24075 17172 17360 17369 17490 24007 24025 38199 17356 17406 17206 17239 17240 17284 17375 17459 17516 23033 24058 24076 35019 35032 35040 17366 17215 17376 17449 17455 17470 34059 34262 38106 17252 34172 38070 38142 17439 38350 74040 17504 34072 35041 38105 17271 17346 24021 24077 24093 24146 34117 34127 34128 34129 34131 34153 34202 35059 38094 38290 38311 17258 38310 34212 38042 38281 17560 38166 38183 24039 34110 38117 17521 38010 38219 17307 38075 38222 34055 38195

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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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