Technomed Europe recalls disposable subdermal needle electrodes with potential MRI burns due to inadequate safety info. Affected lots expire by 2024; stop using if used in MRI.
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.
Technomed Europe is recalling disposable subdermal needle electrodes that could cause burns during MRI scans because the safety instructions were incomplete. This affects patients who have these electrodes left in place while undergoing MRI.
The electrodes may cause burns during MRI scans because the safety instructions did not properly warn about risks. This happens when the electrodes are left in place during the MRI procedure, which can lead to overheating and skin damage.
Patients using these electrodes during MRI scans are most at risk. The recall applies to specific lot numbers of the disposable subdermal needle electrodes.
Check for lot numbers 044220 (exp. 1/1/2023), 045077 (exp. 3/1/2023), 045443 (exp. 4/1/2023), or 049285 (exp. 7/1/2024) on the packaging. The product is a sterile disposable subdermal needle electrode with 25 needles per package.
Look for lot numbers 044220, 045077, 045443, or 049285 on the packaging.
If you used this electrode during an MRI scan, stop using it immediately and contact your healthcare provider.
The recall is because the safety instructions did not adequately warn about the risk of burns during MRI scans when electrodes are left in place.
Check for lot numbers 044220 (exp. 1/1/2023), 045077 (exp. 3/1/2023), 045443 (exp. 4/1/2023), or 049285 (exp. 7/1/2024) on the packaging.
The recall does not specify a return process, so contact the manufacturer directly for instructions.
We’ve drafted a message you can send Technomed Europe to request your refund or repair — edit it as you like.
Subject: Recall Z-1737-2022 — Technomed Europe Technomed Europe Hello, I own a Technomed Europe that is covered by recall Z-1737-2022 from Technomed Europe. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.