Home / Recalls / Philips North America Llc / Z-1798-2025

Z-1798-2025 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

FDA device recall Z-1798-2025 was initiated by Philips North America Llc on May 13, 2025 and is designated Class II. Reason for recall: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The recall status is ongoing. Affected quantity: 152 units (25 US, 127 OUS).

Recall Details

Product Type
Devices
Report Date
May 28, 2025
Initiation Date
May 13, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
152 units (25 US, 127 OUS)

Product Description

Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;

Reason for Recall

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Distribution Pattern

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.

Code Information

Model Numbers: (1) 781359, (2) 782108, (3) 782139; UDI-DI: (1) 00884838090057, (2) 00884838009813, (3) 00884838098299; Serial Numbers: (1) 48001, 48005, 48009, 48011, 48014, 48016, 48023, 48033, 48034, 48043, 48045, 48047, 48122, 48154, 48160, 48167, 48173, 48178, 48179, 48180, 48242, 48275, 48285, (2) 48501, 48503, 48507, 48524, 48530, 48537, 48548, 48549, 48557, 48564, 48566, 48568, 48569, 48571, 48576, 48577, 48580, 48582, 48588, 48589, 48591, 48595, 48607, 48608, 48612, 48614, 48620, 48628, 48638, 48641, 48666, 48667, 48668, 48669, 48671, 48672, 48673, 48686, 48688, 48692, 48694, 48695, 48696, 48697, 48698, 48718, 48721, 48726, 48749, 48778, 48818, 48819, 48831, 48847, 48854, 48878, 48888, 48895, 48907, (3) 29000, 29003, 29005, 29006, 29008, 29009, 29010, 29011, 29012, 29013, 29014, 29015, 29016, 29017, 29018, 29019, 29020, 29021, 29022, 29023, 29025, 29026, 29027, 29029, 29030, 29031, 29032, 29033, 29034, 29035, 29038, 29039, 29040, 29042, 29043, 29045, 29046, 29047, 29048, 29049, 29050, 29052, 29053, 29054, 29055, 29057, 29058, 29060, 29062, 29063, 29064, 29065, 29066, 29067, 29068, 29069, 29070, 29071, 29076, 29078, 29079, 29081, 29083, 29084, 29085, 29088, 29089, 29091, 29093, 29105;

Other recalls by Philips North America Llc

  • Z-2579-2026 Class II — Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the follo (June 5, 2026)
  • Z-2523-2026 Class II — Philips Avalon Fetal Monitor, FM 30 Part numberM2703A (May 26, 2026)
  • Z-2522-2026 Class II — Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A (May 26, 2026)
  • Z-2354-2026 Class II — DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. (May 1, 2026)
  • Z-1955-2026 Class II — Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number ( (April 14, 2026)
  • Z-1960-2026 Class II — Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF) (April 14, 2026)
  • Z-1966-2026 Class II — Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model N (April 14, 2026)
  • Z-1963-2026 Class II — Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): (April 14, 2026)
  • Z-1961-2026 Class II — Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF) (April 14, 2026)
  • Z-1965-2026 Class II — Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model N (April 14, 2026)

FDA data resources