FDA Device recall Z-1804-2025
Product Name: MR 5300
- FDA Device
- Class II
- ongoing
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class II recall of Product Name: MR 5300 by Philips North America, citing potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1804-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-13 |
| Published | 2025-05-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Reason
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Identifiers
| code_info | Model Numbers: (1) 782110, (2) 782152; UDI-DI: (1) 00884838099364, (2) 00884838112841; Serial Numbers: (1) 63007, 63011…Model Numbers: (1) 782110, (2) 782152; UDI-DI: (1) 00884838099364, (2) 00884838112841; Serial Numbers: (1) 63007, 63011, 63022, 63043, 63047, 63050, 63051, 63060, 63074, 63078, 63079, 63082, 63085, 63090, 63095, 63097, 63100, 63116, 63121, 63132, 63136, 63137, 63142, 63143, 63144, 63146, 63150, 63156, 63160, 63162, 63166, 63190, 63202, 63210, 63222, 63226, 63228, 63235, 63238, 63239, 63244, 63247, 63258, 63262, 63263, 63264, 63265, 63266, 63267, 63268, 63269, 63270, 63272, 63274, 63275, 63276, 63281, 63282, 63283, 63284, 63285, 63286, 63287, 63288, 63289, 63290, 63292, 63300, 63303, 63304, 63305, 63306, 63307, 63337, 63352, 63356, 63361, 63363, 63366, 63367, 63370, 63372, 63394, 63456, 63596, 63599, (2) 69000, 69003, 69004, 69005, 69006, 69007, 69008, 69010, 69011, 69012, 69014, 69015, 69016, 69017, 69019, 69020, 69021, 69022, 69023, 69024, 69026, 69027, 69029, 69031, 69032, 69034, 69036, 69037, 69041, 69043, 69044, 69045, 69046, 69048, 69051, 69052, 69053, 69055, 69056, 69058, 69060, |
|---|
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-1804-2025%22
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