FDA Device recall Z-1803-2025
Product Name: 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: 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-1803-2025 |
| 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 X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
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) 781358, (2) 782107, (3) 782136; UDI-DI: (1) 00884838088115, (2) 00884838098336, (3) 00884838108608;…Model Numbers: (1) 781358, (2) 782107, (3) 782136; UDI-DI: (1) 00884838088115, (2) 00884838098336, (3) 00884838108608; Serial Numbers: (1) 45010, 45023, 45028, 45029, 45032, 45033, 45034, 45037, 45040, 45041, 45043, 45045, 45046, 45048, 45049, 45053, 45066, 45070, 45072, 45076, 45087, 45090, 45091, 45092, 45093, 45102, 45105, 45108, 45115, 45116, 45119, 45127, 45136, 45138, 45140, 45144, 45147, 45154, 45156, 45157, 45162, 45168, 45181, 45184, 45189, 45191, 45194, 45205, 45222, 45227, 45231, 45243, 45244, 45245, 45246, 45250, 45252, 45263, 45272, 45277, 45278, 45289, 45290, 45296, 45317, 45319, 45323, 45328, 45333, 45335, 45340, 45342, 45362, 45374, 45379, 45414, (2) 45503, 45508, 45519, 45523, 45525, 45530, 45532, 45533, 45534, 45536, 45542, 45543, 45545, 45547, 45551, 45559, 45560, 45561, 45568, 45573, 45574, 45578, 45580, 45589, 45594, 62011, 62023, 62024, 62026, 62030, 62031, 62033, 62035, 62038, 62040, 62041, 62047, 62048, 62051, 62052, 62056, 62058, 62059, 62061, 62062, 62065, 620 |
|---|
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-1803-2025%22
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