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Moderate riskFDA DeviceClass II

Philips Ingenia 3.0T MRI system recalled for stiffness measurement errors

Philips has identified a software issue in certain Ingenia 3.0T MRI systems that may cause incorrect stiffness values to appear when viewing elastography images on a PACS (picture viewing system). This affects 24 systems worldwide with specific software versions. No injuries have been reported.

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

What to do

  1. Check if your Ingenia 3.0T system has software version R11.1 or R12.1 and matches one of the listed serial numbers
  2. Contact Philips or your service representative to verify if your system is affected
  3. Do not rely on stiffness measurements from affected systems until Philips provides an update
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. 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
24 units
Illnesses reported
None reported
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Classification
Class II
Recall number
Z-1207-2026

In the FDA's words

Description
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. 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): 781342; UDI-DI: 00884838055339; Serial Numbers: 71607, 85216, 71087, 71619, 71462, 71002, 71885, 71841, 71378, 71269, 85126, 71279, 71088, 71185, 71532, 71344, 71756, 71336, 71459. (2) Product Code (REF): 781377; UDI-DI: 00884838009813; Serial Numbers: 42305, 42299, 42036, 42376, 42321. 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: 24 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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