Recall archive / FDA device enforcement
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140; — FDA record Z-1795-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 13, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
- Reason
- Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Classification
- Class II
- Recalling firm
- Philips North America Llc
- Quantity
- 264 units (46 US, 218 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1795-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140; UDI-DI: (1) 00884838099715, (2) 00884838055322, (3) 00884838009820, (4) 00884838098275, (5) 00884838099043, (6) 00884838108646; Serial Numbers: (1) 61003, 61005, 61007, 61014, 61022, 61023, 61024, 61029, 61031, 61033, 61036, 61045, 61051, 61052, 61053, 61054, 61055, 61057, 61059, 61062, 61063, 61076, 61088, 61093, 61097, 61101, 61112, 61124, (2) 70009, 70042, 70051, 70056, 70059, 70075, 70095, 70104, 70203, 70223, 70249, 70257, 70262, 70300, 70311, 70346, 70376, 70381, 70383, 70427, 70432, 70439, 70440, 70453, 70460, 70461, 70472, 70483, 70588, 70596, 70598, 70619, 70645, 70646, 70647, 70650, 70658, 70659, 70661, 70672, 70684, 70699, 70702, 70708, 70712, 70724, 70736, 70741, 70751, 70798, 70800, 70820, 70825, 70826, 70836, 70846, 70862, 70863, 70880, 70886, 70889, 70896, 70897, 70902, 70920, 70922, 70953, 70961, 70970, 70975, 70977, 70979, 70983, 70988, 70989, 84027, 84031, 84034, 84042, 84043, 84076, 84079, 84080, 84084, 84085, 84093, 84118, 84130, 84136, 84141, 84157, 84170, 84172, 84173, 84185, 84186, 84191, 84193, 84202, 84203, 84205, 84210, 84212, 84226, 84233, 84253, 84266, 84267, 84270, 84276, 84281, 84295, 84332, 84333, 84335, 84343, 84359, 84360, 84376, 84379, 84388, 84394, 84416, 84419, 84429, 84431, 84448, 84462, 84484, 84485, 84487, 84507, 84509, 84528, 84539, 84545, 84549, 84550, 84555, 84560, 84568, 84596, 84628, 84634, 84635, 84641, 84654, 84694, 84708, 84713, 84721, 84722, 84725, 84741, 84745, 84750, 84768, 84788, 84803, 84828, 84838, 84839, 84840, 84850, 84853, 84858, 84867, 84869, 84880, 84892, 84893, 84904, 84918, 84939, 84954, 84956, 84973, 84978, 87026, 87040, 87068, 87076, 87121, 87196, 87245, 87255, 87259, (3) 41000, 41003, 41021, 41029, 41033, 41034, 41055, 41061, 41071, 41088, 41109, 41123, 41131, 41174, 41182, 41215, 41216, 41249, 41251, 41254, 41255, 41259, 41262, 41311, 41312, 41336, 41349, 41356, 41358, 41363, 41370, 41384, 41387, 41388, 41389, 41400, 41402, 41412, 41422, 41499, 41500, 41515, 41538, 41548, (4) 87655, (5) 61383, 61384, 61412, (6) 45601; |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 28, 2025
- Recall initiation date
- May 13, 2025
- Center classification date
- May 16, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.