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FDA-Device2026-02-04Class IIPROCESSING DEFECT

Philips MR 7700 MRI system recalled for stiffness value display errors

Philips
OTHERNationwide distribution

Check Philips MR 7700 MRI stiffness readings

Philips MR 7700 MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when elastography maps are exported to medical imaging viewing systems. This affects 9 units worldwide. No injuries have been reported.

  • If you operate a Philips MR 7700 system, verify your software version (R11.1 or R12.1)
  • Review any elastography stiffness results already viewed or shared through PACS
  • Contact Philips North America for a software update or corrective guidance
Hazard

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Sold states
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 count
9 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1213-2026

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