Recall Weekly
Moderate riskFDA DeviceClass II

Philips Ingenia Elition S MRI system recalled for stiffness value errors in elastography maps

Philips Ingenia Elition S MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when MR Elastography maps are exported to a PACS (Picture Archiving and Communication System). This could affect the accuracy of tissue stiffness measurements used in clinical evaluation. Five units worldwide have been identified.

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

What to do

  1. If you operate an affected Ingenia Elition S system (serial numbers 46002, 46243, 46292, 64034, or 64045), contact Philips support immediately
  2. Do not rely on exported MRE stiffness values from these systems until the issue is resolved
  3. Verify your system software version and serial number against the recall details
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 13 products — see all of them.

Details

Units affected
5 units
Illnesses reported
None reported
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Classification
Class II
Recall number
Z-1211-2026

In the FDA's words

Description
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. 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): 781357; UDI-DI: 00884838088108; Serial Numbers: 46002. (2) Product Code (REF): 782106; UDI-DI: 00884838098329; Serial Numbers: 46243, 46292. (3) Product Code (REF): 782137; UDI-DI: 00884838108615; Serial Numbers: 64034, 64045. 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: 5 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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