Philips North America: Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Nu

Company / brand

Philips North America

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 / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2026-04-14

Code info

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.

Product quantity

86 units

Voluntary mandated

Voluntary: Firm initiated

City

Cambridge

State

MA

Country

United States

Event id

98779

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