Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

FDA Recall Z-0975-2024 · Posted 2024-02-02

Recalling FirmPhilips North America
Recall StatusOpen, Classified
Product CodeLNH
Date Initiated2022-01-06
Product Quantity10

Reason for Recall

Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

Firm Action

Beginning in January 2022, Philips Field Service Engineers (FSE) visited impacted customer sites to replace the magnetic castor wheels of the HA Flextrack Trolley II with non-magnetic castor wheels. All reachable systems were addressed as of August 10, 2023.

Root Cause

Device Design

Distribution Pattern

Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K193215Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2020-04-10K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2019-02-14K181479Ingenia Ambition S and Ingenia Ambition XPhilips Medical Systems Nederland B.V. · 2018-08-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑