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MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images a...

FDA Device Recall #Z-3201-2024 — Class II — September 3, 2024

Recall Summary

Recall Number Z-3201-2024
Classification Class II — Moderate risk
Date Initiated September 3, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips North America Llc
Location Cambridge, MA
Product Type Devices
Quantity 68 units

Product Description

MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110

Reason for Recall

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Maldives, Mauritius, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam.

Lot / Code Information

UDI-DI: (01)00884838099364(21) Serial Numbers: 63027 63035 63039 63066 63068 63070 63076 63078 63083 63084 63086 63092 63094 63096 63097 63103 63104 63106 63109 63112 63113 63115 63122 63123 63125 63128 63130 63132 63135 63137 63140 63141 63142 63143 63144 63146 63148 63149 63150 63151 63152 63154 63157 63160 63161 63168 63169 63172 63174 63177 63178 63183 63186 63190 63191 63193 63197 63201 63203 63211 63229 63238 63248 63263 63272 63288 63367 63370

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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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