Device product
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Z-1737-2022
Product summary
- Firm
- Technomed Europe
- Event
- Event 90733
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37/25-electrode boxes
- Official record key
device-enforcement:Z-1737-2022
Official wording
Reason: Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
Code information: Lot numbers 044220, exp. 1/1/2023; 045077, exp. 3/1/2023; 045443, exp. 4/1/2023; and 049285, exp. 7/1/2024; UDI-DI 08718375861530.
Distribution pattern: US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
Derived failure modes
-
Unknown
Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.