Recall archive / FDA device enforcement
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. ... — FDA record Z-1961-2026
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 Apr 14, 2026. 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
- Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
- Reason
- The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Classification
- Class II
- Recalling firm
- Philips North America
- Quantity
- 86 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1961-2026
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 | 1. Model Number (REF): 781356. UDI: (01)00884838090040(21)47056, (01)00884838090040(21)47272, (01)00884838090040(21)47189, (01)00884838090040(21)47310, (01)00884838090040(21)47006, (01)00884838090040(21)47029, (01)00884838090040(21)47044, (01)00884838090040(21)47068, (01)00884838090040(21)47196, (01)00884838090040(21)47206, (01)00884838090040(21)47208, (01)00884838090040(21)47237, (01)00884838090040(21)47260, (01)00884838090040(21)47289, (01)00884838090040(21)47291, (01)00884838090040(21)47294, (01)00884838090040(21)47303, (01)00884838090040(21)47305, (01)00884838090040(21)47322, (01)00884838090040(21)47325, (01)00884838090040(21)47330, (01)00884838090040(21)47339, (01)00884838090040(21)47380, (01)00884838090040(21)47387. Serial Numbers: 47056, 47272, 47189, 47310, 47006, 47029, 47044, 47068, 47196, 47206, 47208, 47237, 47260, 47289, 47291, 47294, 47303, 47305, 47322, 47325, 47330, 47339, 47380, 47387. 2. Model Number (REF): 782109. UDI: (01)00884838098350(21)47869, (01)00884838098350(21)47565, (01)00884838098350(21)47644, (01)00884838098350(21)47881, (01)00884838098350(21)47509, (01)00884838098350(21)47919, (01)00884838098350(21)47634, (01)00884838098350(21)47681, (01)00884838098350(21)47706, (01)00884838098350(21)47907, (01)00884838098350(21)47867, (01)00884838098350(21)47550, (01)00884838098350(21)47804, (01)00884838098350(21)47549, (01)00884838098350(21)47635, (01)00884838098350(21)47788, (01)00884838098350(21)47617, (01)00884838098350(21)47566, (01)00884838098350(21)47597, (01)00884838098350(21)47892, (01)00884838098350(21)47893, (01)00884838098350(21)47894, (01)00884838098350(21)47534, (01)00884838098350(21)47538, (01)00884838098350(21)47554, (01)00884838098350(21)47590, (01)00884838098350(21)47642, (01)00884838098350(21)47659, (01)00884838098350(21)47726, (01)00884838098350(21)47760, (01)00884838098350(21)47761, (01)00884838098350(21)47767, (01)00884838098350(21)47771, (01)00884838098350(21)47789, (01)00884838098350(21)47799, (01)00884838098350(21)47814, (01)00884838098350(21)47835, (01)00884838098350(21)47849, (01)00884838098350(21)47862, (01)00884838098350(21)47888, (01)00884838098350(21)47929, (01)00884838098350(21)47931, (01)00884838098350(21)47950, (01)00884838098350(21)47962. Serial Numbers: 47869, 47565, 47644, 47881, 47509, 47919, 47634, 47681, 47706, 47907, 47867, 47550, 47804, 47549, 47635, 47788, 47617, 47566, 47597, 47892, 47893, 47894, 47534, 47538, 47554, 47590, 47642, 47659, 47726, 47760, 47761, 47767, 47771, 47789, 47799, 47814, 47835, 47849, 47862, 47888, 47929, 47931, 47950, 47962. 3. Model Number (REF): 782138. UDI: (01)00884838108622(21)49004, (01)00884838108622(21)49251, (01)00884838108622(21)49045, (01)00884838108622(21)49058, (01)00884838108622(21)49129, (01)00884838108622(21)49153, (01)00884838108622(21)49165, (01)00884838108622(21)49161, (01)00884838108622(21)49205, (01)00884838108622(21)49228, (01)00884838108622(21)49206, (01)00884838108622(21)49057, (01)00884838108622(21)49100, (01)00884838108622(21)49172, (01)00884838108622(21)49210, (01)00884838108622(21)49215, (01)00884838108622(21)49231. Serial Numbers: 49004, 49251, 49045, 49058, 49129, 49153, 49165, 49161, 49205, 49228, 49206, 49057, 49100, 49172, 49210, 49215, 49231. 4. Model Number (REF): 782160. UDI: (01)00884838115712(21)92039. Serial Numbers: 92039. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.
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 6, 2026
- Recall initiation date
- Apr 14, 2026
- Center classification date
- Apr 27, 2026
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.