Recall Weekly
Moderate riskFDA DeviceClass II

Philips Ingenia Ambition S. MRI system recalled for stiffness value errors

Philips has recalled certain Ingenia Ambition S. MRI systems (software versions R11.1 and R12.1) because they may display incorrect stiffness values when MR Elastography images are sent to a PACS (picture viewing system). This could affect the accuracy of medical imaging data used for diagnosis.

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

What to do

  1. If your facility operates an Ingenia Ambition S. MRI system, contact Philips North America to determine if your device is affected
  2. Do not rely on exported MRE stiffness values until Philips confirms your device is unaffected or provides instructions
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Ingenia Ambition S. Product Code (REF): 782108. 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
1 unit
Illnesses reported
None reported
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Classification
Class II
Recall number
Z-1209-2026

In the FDA's words

Description
Ingenia Ambition S. Product Code (REF): 782108. 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. Product Code (REF): 782108. UDI-DI: 00884838098343. Serial Numbers: 48669. 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: 1 unit
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.

More from Philips

See all

Related topics

OtherSoftwareMedical devicesSold nationwideMore from FDA Device