RecallRadar

FDA Device recall Z-1801-2025

Product Name: Ingenia Ambition X

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

AgencyFDA Device
Recall numberZ-1801-2025
ClassificationClass II
Statusongoing
Initiated2025-05-13
Published2025-05-28
Last updated2026-09-13 11:57 UTC
CompanyPhilips North America
DistributionUS

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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