—#205343

Product

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

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181479, K183063, K193215
Affected lot / code info: UDI-DI 00884838090040 Ingenia Serial number / Accessory Serial Number 47004 100020 47019 100024 47190 100022 47200 100025 47210 100019 47227 100063 47231 100056 47271 100032 47281 100028 47281 100031

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

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

Timeline

Recall initiated: 2022-01-06
Posted by FDA: 2024-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205343. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.