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Moderate riskFDA DeviceClass II

Philips Ingenia Ambition X MRI system recalled for stiffness value errors in elastography maps

Philips has identified a potential error in how stiffness values are displayed when MR Elastography (MRE) images are exported to a PACS viewer on certain Ingenia Ambition X MRI systems. This affects 21 systems worldwide running software versions R11.1 or R12.1. The error could result in incorrect stiffness measurements being shown to clinicians.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. If you operate an Ingenia Ambition X MRI system, verify your software version (R11.1 or R12.1) and check your serial number against the FDA recall notice
  2. Contact Philips North America immediately if your system is affected
  3. Do not rely on exported MRE stiffness maps until you receive further guidance from Philips
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 13 products — see all of them.

Details

Units affected
21 units
Illnesses reported
None reported
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Classification
Class II
Recall number
Z-1210-2026

In the FDA's words

Description
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1. The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). 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. Distribution: 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. Affected quantity: 21 units
Hazard
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

13 products in this recall

Philips Ingenia and Evolution MRI systems recalled for stiffness errors

Philips is recalling 13 MR imaging system products because exported MR Elastography stiffness maps may show incorrect stiffness values when viewed in a PACS image viewer. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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