Recall Weekly
Moderate riskFDA DeviceClass II

Philips Evolution Upgrade 1.5T MRI recalled for stiffness value errors in elastography maps

Philips Evolution Upgrade 1.5T MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography maps are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used in clinical diagnosis. Three units have been identified worldwide.

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

What to do

  1. Contact Philips if you operate an affected MRI system (product codes 782148 or 782116 with software R11.1 or R12.1)
  2. Do not rely on exported elastography stiffness maps until you receive guidance from Philips
  3. Request a software update or corrective action from Philips North America
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. 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
3 units
Illnesses reported
None reported
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Classification
Class II
Recall number
Z-1204-2026

In the FDA's words

Description
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. 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): 782148. UDI-DI: 00884838108714. Serial Numbers: 70769, 70983. (2) Product Code (REF): 782116. UDI-DI: 00884838099722. Serial Number: 84741. 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: 3 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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