FDA Device recall Z-3241-2026
MR 5300 Model Number (REF): 1. 782110, 2. 782152
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of MR 5300 Model Number (REF): 1. 782110, 2. 782152 by Philips North America, citing A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3241-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-21 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Philips North America |
| Distribution | US |
Product
MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Reason
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Identifiers
| code_info | 1. Model Number (REF): 782110; UDI-DI: 884838099364; Serial Numbers: 63383, 63384, 63385, 63386, 63422, 63435, 63643, 6…1. Model Number (REF): 782110; UDI-DI: 884838099364; Serial Numbers: 63383, 63384, 63385, 63386, 63422, 63435, 63643, 63346, 63021, 63054, 63091, 63092, 63113, 63313, 63314, 63315, 63322, 63521, 63524, 63565, 63572, 63593, 63604, 63639, 63694, 63697, 63705, 63706, 63707, 63716, 63721, 63727, 63736, 63737, 63739, 63743, 63750, 63753, 63754, 63755, 63769, 63773, 63617, 63560, 63038, 63484, 63023, 63064, 63066, 63075, 63086, 63149, 63161, 63183, 63194, 63195, 63198, 63199, 63308, 63319, 63331, 63334, 63336, 63364, 63371, 63412, 63425, 63429, 63430, 63452, 63515, 63525, 63609, 63615, 63633, 63636, 63638, 63666, 63668, 63675, 63687, 63689, 63690, 63695, 63696, 63729, 63730, 63742, 63763, 63765, 63774, 63787, 63806, 63829, 63686, 63193, 63257, 63431, 63583, 63592, 63123, 63155, 63474, 63576, 63416, 63748, 63337, 63456, 63046, 63157, 63357, 63569, 63000, 63325, 63504, 63506, 63104, 63110, 63115, 63186, 63248, 63250, 63252, 63343, 63344, 63586, 63785, 63820, 63821, 63328, 63664, 63771, 63457, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Philips North America
- Ingenia 3.0T and 3.0T CX
FDA Device · Class II · 2026-10-07 · Philips North America - MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - SmartPath to MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - Upgrade to MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - Upgrade dStream
FDA Device · Class II · 2026-10-07 · Philips North America
All Philips North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3241-2026%22
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