Reported May 6, 2026 · Ongoing
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3.…
Philips North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America · 222 Jacobs St · Cambridge, MA · 02141-2296
Is this the product you have?
- 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
- Lot codes and dates
- 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
470564727247189473104700647029470444706847196472064720847237472604728947291472944730347305473224732547330473394738047387. 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
4786947565476444788147509479194763447681477064790747867475504780447549476354778847617475664759747892478934789447534475384755447590476424765947726477604776147767477714778947799478144783547849478624788847929479314795047962. 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
4900449251490454905849129491534916549161492054922849206490574910049172492104921549231. 4
- Model Number (REF)782160
- UDI(01)00884838115712(21)92039
- Serial Numbers92039
- Amount recalled
- 86 units
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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