FDA-Device2026-02-04Class IIPROCESSING DEFECT
Philips MR 7700 MRI systems recalled for elastography stiffness value errors
What this means
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.
- If you operate a Philips MR 7700 system, check your software version
- Contact Philips for a software upgrade if you are running R11.1 or R12.1
- Do not rely on elastography stiffness values from exported images until your system is updated
The agency's original wording
Hazard
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Intended for
Adults
Illnesses reported
None reported
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
6 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1214-2026Want us to check the next one for you?
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