FDA Device recall Z-1801-2025
Product Name: Ingenia Ambition 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 Ambition 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-1801-2025 |
| 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 Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
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) 781356, (2) 782109, (3) 782138; UDI-DI: (1) 00884838090040, (2) 00884838098350, (3) 00884838108622;…Model Numbers: (1) 781356, (2) 782109, (3) 782138; UDI-DI: (1) 00884838090040, (2) 00884838098350, (3) 00884838108622; Serial Numbers: (1) 47002, 47004, 47011, 47012, 47018, 47019, 47020, 47028, 47029, 47037, 47049, 47052, 47057, 47099, 47173, 47184, 47187, 47189, 47200, 47203, 47204, 47206, 47211, 47215, 47222, 47230, 47231, 47242, 47245, 47252, 47258, 47260, 47268, 47270, 47274, 47281, 47283, 47286, 47290, 47294, 47297, 47301, 47304, 47309, 47312, 47313, 47314, 47328, 47342, 47347, 47351, (2) 47503, 47505, 47507, 47508, 47514, 47519, 47520, 47522, 47530, 47535, 47536, 47539, 47543, 47558, 47560, 47561, 47562, 47563, 47567, 47568, 47572, 47580, 47595, 47596, 47598, 47599, 47608, 47610, 47614, 47615, 47622, 47623, 47634, 47642, 47646, 47649, 47651, 47653, 47654, 47657, 47661, 47662, 47663, 47668, 47669, 47671, 47678, 47681, 47682, 47685, 47687, 47689, 47692, 47694, 47697, 47698, 47702, 47706, 47708, 47709, 47710, 47717, 47718, 47721, 47726, 47727, 47728, 47729, 47730, 47731, 47732, 47 |
|---|
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-1801-2025%22
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