FDA Device recall Z-3201-2024
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of…
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of… by Philips North America, citing 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 bl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3201-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-03 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | UDI-DI: (01)00884838099364(21) Serial Numbers: 63027 63035 63039 63066 63068 63070 63076 63078 63083 63084 63086 63092…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3201-2024%22
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