Recall Z-1207-2026— Philips North America

Name: FDA recall Z-1207-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-03

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2025-12-03. It names one FDA 510(k) clearance: K193215. Product: Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.. Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2025-12-03
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.·cleared 2020-04-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.