The Recall Desk
HighFDA (Devices)·Z-1204-2026·Announced 2026-02-04

Evolution Upgrade 1.5T systems recalled over elastography stiffness value errors

Philips North America is recalling 3 units of the Evolution Upgrade 1.5T MR system because exported MR Elastography stiffness maps may show stiffness value errors.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states exported elastography maps may show incorrect stiffness values, and no injuries are reported.

Plain-English summary

The Philips Evolution Upgrade 1.5T, product codes 782148 and 782116, covering MR systems with software versions R11.1 and R12.1, is being recalled by Philips North America.

The reason given in the enforcement record is the potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps in a viewer Picture Archiving and Communication System (PACS).

The record lists 3 units, with UDI-DI codes and serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.

An incorrect stiffness value is a measurement a clinician reads. The enforcement record reports no injuries. Facilities should follow Philips' instructions.

The recalled product

Product
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Manufacturer
Philips North America
Category
Medical Device — MRI
Hazard
  • measurement-error
  • elastography
  • pacs-export
  • mri

Distribution

Distributed nationwide across the United States.

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