Recall Weekly
Moderate riskFDA DeviceClass II

Philips MR 7700 MRI systems recalled for elastography stiffness value errors

Philips MR 7700 MRI systems running software versions R11.1 or R12.1 may display incorrect stiffness values when MR Elastography images are exported to a PACS viewer. This could affect the accuracy of tissue stiffness measurements used in clinical evaluation.

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

What to do

  1. If you operate a Philips MR 7700 system, check your software version
  2. Contact Philips for a software upgrade if you are running R11.1 or R12.1
  3. Do not rely on elastography stiffness values from exported images until your system is updated
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Upgrade to MR 7700. Product Code (REF): 782130. 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
6 units
Illnesses reported
None reported
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Classification
Class II
Recall number
Z-1214-2026

In the FDA's words

Description
Upgrade to MR 7700. Product Code (REF): 782130. 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): 782130. UDI-DI: 00884838104402. Serial Numbers: 42030, 85644, 42163, 42151, 45236, 85643. 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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