Recall Z-1737-2022 ยท IKT Electrode, Needle, Diagnostic Electromyograph
Technomed Europe
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
| Date | Aug 9, 2022 |
| 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. |
| Root cause | Labeling Change Control |
| Action | 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 Instruction |
| Quantity | 37/25-electrode boxes |
| Distribution | US Nationwide distribution in the states of CA, FL, NH, OH, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, Technomed Europe, Jul 19, 2013 |