FDA Device recall Z-1791-2025
Product Name: SmartPath to Ingenia Elition X
- 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 Ingenia Elition X 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-1791-2025 |
| 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 Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
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) 782118, (2) 782144; UDI-DI: (1) 00884838099746, (2) 00884838108677; Serial Numbers: (1) 42072, 42194…Model Numbers: (1) 782118, (2) 782144; UDI-DI: (1) 00884838099746, (2) 00884838108677; Serial Numbers: (1) 42072, 42194, 42306, 71019, 71025, 71050, 85661, 85676, (2) 42062, 42105, 42323, 42346, 42441, 71278, 71504, 71508; |
|---|
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-1791-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.