FDA Device recall Z-1802-2025
Product Name: Ingenia Elition S
- FDA Device
- Class II
- ongoing
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class II recall of Product Name: Ingenia Elition S 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-1802-2025 |
| 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: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
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) 781357, (2) 782106, (3) 782137; UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615;…Model Numbers: (1) 781357, (2) 782106, (3) 782137; UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615; Serial Numbers: (1) 46002, 46004, 46007, 46012, 46013, 46015, 46016, 46018, 46020, 46021, 46023, 46025, 46039, 46049, 46054, 46068, 46076, 46082, 46085, 46092, 46101, (2) 46203, 46206, 46207, 46208, 46209, 46219, 46220, 46225, 46235, 46237, 46241, 46242, 46243, 46245, 46258, 46268, 46269, 46270, 46286, 46292, 46326, (3) 64001, 64002, 64003, 64004, 64005, 64007, 64008, 64009, 64011, 64013, 64014, 64015, 64016, 64019, 64022, 64023, 64024, 64028, 64029, 64030, 64032, 64034, 64045; |
|---|
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-1802-2025%22
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