Recall Z-0974-2024— Philips North America
Class II · Ongoing
Class II FDA medical device recall by Philips North America, initiated 2022-01-06. It names 2 FDA 510(k) clearances: K173451, K173356. Product: Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system. Reason: 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..
- Recalling firm
- Philips North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-06
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K173451 — Ingenia Elition S and Ingenia Elition X
- K173356 — Ingenia Elition S and Ingenia Elition X R5.4
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 Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.