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FDADecember 3, 2025device

MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

0088483810411200884838112858

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1. — Recall Details · AllClear