FDA Device recall Z-1790-2025
Product Name: SmartPath to dStream for XR and 3.0T
- FDA Device
- Class II
- ongoing
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class II recall of Product Name: SmartPath to dStream for XR and 3.0T 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-1790-2025 |
| 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: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
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) 781270, (2) 782113; UDI-DI: (1) 00884838095083, (2) 00884838098909; Serial Numbers: (1) 17283, 17299…Model Numbers: (1) 781270, (2) 782113; UDI-DI: (1) 00884838095083, (2) 00884838098909; Serial Numbers: (1) 17283, 17299, 17321, 17356, 17357, 17369, 17378, 17398, 17416, 17425, 17473, 17490, 17499, 17550, 17564, 17565, 17569, 17589, 17590, 17594, 23026, 24012, 24023, 24066, 24075, 24087, 24090, 24110, 34107, 34152, 35043, 35047, 35056, 38004, 38023, 38084, 38089, 38113, 38120, 38199, 38202, 38300, 38366, (2) 17252, 17258, 17346, 24039, 24077, 24146, 34131, 34212, 35071, 38197, 38234, 38291; |
|---|
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-1790-2025%22
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