Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Summary
The FDA issued a Class II for Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 78 by Philips North America Llc. Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application..
Details
Source
Device Recall
External ID
Z-1801-2025
Action Date
2025-05-28
Status
Ongoing
Category
device
Product Description
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Lot/Code Info: 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, 47733, 47748, 47751, 47760, 47761, 47762, 47767, 47771, 47778, 47779, 47780, 47781, 47782, 47783, 47789, 47796, 47797, 47800, 47801, 47808, 47809, 47812, 47815, 47816, 47817, 47818, 47820, 47822, 47826, 47834, 47839, 47843, 47844, 47849, 47851, 47862, 47863, 47866, 47876, 47882, 47885, 47886, 47887, 47891, 47928, (3) 49000, 49001, 49002, 49003, 49004, 49008, 49009, 49010, 49013, 49014, 49015, 49017, 49019, 49020, 49021, 49025, 49026, 49027, 49029, 49031, 49033, 49034, 49036, 49043, 49044, 49045, 49047, 49048, 49049, 49052, 49053, 49054, 49056, 49057, 49058, 49060, 49062, 49063, 49064, 49066, 49067, 49068, 49069, 49070, 49071, 49072, 49073, 49075, 49076, 49077, 49078, 49079, 49080, 49081, 49086, 49087, 49088, 49089, 49090, 49091, 49092, 49093, 49094, 49095, 49096, 49097, 49098, 49099, 49100, 49101, 49102, 49103, 49104, 49105, 49106, 49107, 49108, 49109, 49110, 49111, 49113, 49114, 49115, 49116, 49117, 49118, 49119, 49121, 49124, 49128, 49129, 49130, 49131, 49134, 49136, 49140, 49144, 49145, 49146, 49147, 49148, 49152, 49153, 49154, 49155, 49156, 49157, 49158, 49160, 49161, 49162, 49163, 49164, 49165, 49166, 49168, 49171, 49172, 49178, 49179, 49180, 49181, 49182, 49183, 49186, 49197, 49203, 49205, 49212, 49217, 49226, 49227, 49231;
Quantity Affected: 300 units (81 US, 219 OUS)
Reason for Recall
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Distribution
Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-13
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1801-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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