Notice names this product. Philips North America’s Philips Ingenia Ambition X with MR Elastography (MRE) is named in FDA Class II recall Z-1961-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: 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.. Units affected: 86 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 …
Company / brand: Philips North America recalls
Affected product: Philips Ingenia Ambition X with MR Elastography (MRE) recall status
Official ID Z-1961-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.