Recall Z-3243-2026— Philips North America Llc

Name: FDA recall Z-3243-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-21

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2026-08-21. It names 6 FDA 510(k) clearances: K251808, K230972, K213583 and 3 more. Product: SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X);. Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2026-08-21
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

6 on FDA's record

K251808 — Achieva +10 morePhilips Medical Systems Nederland B.V.·cleared 2025-07-11
K230972 — Ingenia Elition and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V.·cleared 2023-04-28
K213583 — Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.·cleared 2022-05-16
K213516 — Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiPhilips Medical Systems Nederland B.V.·cleared 2022-03-03
K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.·cleared 2020-04-10
K110151 — ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TPhilips Health Care·cleared 2011-03-22

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

SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X);

Reason for recall

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

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