CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report

Ingenia Ambition X recalled by Philips North America

Philips North America is recalling Ingenia Ambition X, distributed nationwide in the US. The recall was initiated on 3 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781356; UDI-DI: 00884838090040; Serial Numbers: 47206, 47038, 47068, 47260, 47294, 47029, 47189. (2) Product Code (REF): 782109; UDI-DI: 00884838098350; Serial Numbers: 47849, 47634, 47534, 47726, 47760, 47706, 47789, 47642, 47681, 47761, 47771, 47767, 47862. (3) Product Code (REF): 782138; UDI-DI: 00884838108622; Serial Numbers: 49057.

Quantity recalled21 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1210-2026
FDA event ID: 98111
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 3 Dec 2025
FDA classified: 29 Jan 2026
Reported: 4 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Dec 2025	Recall initiated by company
29 Jan 2026	Classified by FDA	+57 days
4 Feb 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Product as listed by the FDA

Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

Where it was distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.

Nationwide Arizona California Colorado Illinois Massachusetts Maine Michigan Minnesota Mississippi Nebraska New York Ohio Oregon Pennsylvania South Carolina Tennessee Texas Virginia Vermont Washington

Questions about this recall

Is Ingenia Ambition X recalled?

Yes. Philips North America recalled Ingenia Ambition X on 3 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1210-2026.

Why was it recalled?

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Which lots are affected?

MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781356; UDI-DI: 00884838090040; Serial Numbers: 47206, 47038, 47068, 47260, 47294, 47029, 47189. (2) Product Code (REF): 782109; UDI-DI: 00884838098350; Serial Numbers: 47849, 47634, 47534, 47726, 47760, 47706, 47789, 47642, 47681, 47761, 47771, 47767, 47862. (3) Product Code (REF): 782138; UDI-DI: 00884838108622; Serial Numbers: 49057.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips North America

All 531

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
26 Aug 2026Device	CLASS II	Cardiac Workstation recalled by Philips North America	Philips North America	Labeling Errors	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide