Technomed Europe recallZ-1737-2022 · Technomed Europe · initiated Aug 9, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Technomed Europe or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
The recalling firm issued letters dated 8/9/2022 that were flagged "MRI Safety Information." The letter provided an overview of the issue, the affected devices and lot numbers, a description of the issue including the MRI Safety Information that was added to the Instructions for Use, the hazard, and the actions to be taken. The actions included the consignee is to read the Field Safety Notice, review the list of affected products, inform customers who received or will receive products from the affected lot numbers about the issue by forwarding a copy of the notice and the updated Instructions for Use to them, and complete and sign the enclosed acknowledgment form to indicate they have read the notice, understand its content, and will follow the instructions as intended. The form is to be returned via email.
Recall details
- Recall number
- Z-1737-2022
- Status
- Terminated
- Initiated by the company
- Aug 9, 2022
- Recalling firm
- Technomed Europe
- Quantity
- 37/25-electrode boxes
- Product code
- IKT
- FDA submissions
- K130136
- Distribution
- US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
Product description
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Technomed Europe TE/S46-638Technomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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