Z-1737-2022Class II

Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package...

Name: Z-1737-2022 Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package...
Creator: Technomed Europe
Published: 2022-08-09
License: https://open.fda.gov/license/

Technomed Europe / initiated 2022-08-09 / Terminated / root cause: labeling and UDI

FDA source

Technomed Europe began a recall of Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile on 2022-08-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1737-2022
Classification: Class II
Status: Terminated
Initiated: 2022-08-09
Posted: 2022-09-12
Terminated: 2024-04-11
Recalling firm: Technomed Europe
Product: Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Product code: IKT Electrode, Needle, Diagnostic Electromyograph
Reason for recall: 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 tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 37/25-electrode boxes
Distribution: US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1737-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1737-2022	Class II	Terminated	Voluntary: Firm initiated	2022-09-21	2022-09-12

Product code IKT

K130136Class IIDisposable and Reusable Concentric Needle Electrodes,disposable and Reusable Subdermal Needle Electrodes,Technomed Europe / cleared 2013-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)