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Moderate riskFDA DeviceClass II

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

Philips has recalled certain Ingenia 1.5T MRI systems with software versions R11.1 and R12.1. When MR Elastography stiffness maps are exported to a PACS viewer, the stiffness values may display incorrectly. This could affect the accuracy of diagnostic information viewed in those systems.

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

What to do

  1. If your facility operates an affected Ingenia 1.5T MRI system, contact Philips North America for instructions
  2. Check your system's software version (R11.1 or R12.1) and product code (781341 or 781396)
  3. Do not use exported MR Elastography stiffness maps in PACS until Philips provides guidance
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. 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
10 units
Illnesses reported
None reported
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Classification
Class II
Recall number
Z-1206-2026

In the FDA's words

Description
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. 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): 781341; UDI-DI: 00884838055322; Serial Numbers: 70311, 84560, 84403, 84467, 84462, 70042, 84433. (2) Product Code (REF): 781396; UDI-DI: 00884838009820; Serial Numbers: 41356, 41354, 41370. 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: 10 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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