FDA recall Z-0975-2024

Product

Ingenia Ambition X (Product Number 781356) - 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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2022-01-06

Report date

2024-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0975-2024