Device product
Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Z-0973-2024
Product summary
- Event
- Event 93737
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0973-2024
Official wording
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.
Code information: UDI-DI 00884838009820 Ingenia Serial number 41045 Accessory Serial Number 100018
Distribution pattern: Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.
Derived failure modes
-
Unknown
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.