Class II — Technomed Europe
| Recalling firm | Technomed Europe |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile. |
| Quantity | 37/25-electrode boxes |
| Distribution | US Nationwide distribution in the states of CA, FL, NH, OH, and WA. |
| Initiated | 2022-08-09 |
| Classified | 2022-09-12 |
| Terminated | 2024-04-11 |
| Recall number | Z-1737-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Technomed Europe (Z-1737-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90733/
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