Recall Weekly
Moderate riskFDA DeviceClass II

Philips Ingenia 3.0T CX MRI system recalled for stiffness value errors in elastography maps

Philips has recalled certain Ingenia 3.0T CX MRI systems (software versions R11.1 and R12.1) because stiffness values displayed in exported elastography maps may be inaccurate when viewed in a PACS (Picture Archiving and Communication System). This affects 6 units worldwide, primarily in the United States and Europe.

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

What to do

  1. If your facility operates an affected Ingenia 3.0T CX system, contact Philips North America immediately for guidance
  2. Do not rely on elastography stiffness values from exported maps until you receive instructions from Philips
  3. Check your system's serial number against the list provided by Philips to confirm whether you are affected
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Ingenia 3.0T CX. Product Code (REF): 781271. 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
6 units
Illnesses reported
None reported
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Classification
Class II
Recall number
Z-1208-2026

In the FDA's words

Description
Ingenia 3.0T CX. Product Code (REF): 781271. 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): 781271. UDI-DI: 00884838068452. Serial Numbers: 78017, 78112, 78217, 78123, 78260, 78239. 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: 6 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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