[Recalled] Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile. — Burns of varying degrees can occur to patients with electrodes left in while in… | FDA 2022-08-09
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile. |
|---|---|
| Brand / manufacturer | Technomed Europe |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1737-2022 |
| Country of notice | Netherlands |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 09 August 2022 |
| EAN / barcode | 08718375861530 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in Netherlands and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Technomed Europe
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.