Recall Z-1737-2022— Technomed Europe

Name: FDA recall Z-1737-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-09

Class II · Terminated

Class II FDA medical device recall by Technomed Europe, initiated 2022-08-09, terminated 2024-04-11. It names one FDA 510(k) clearance: K130136. Product: Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.. 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..

Recalling firm: Technomed Europe
Classification: Class II
Status: Terminated
Initiated: 2022-08-09
Terminated: 2024-04-11
Firm location: Maastricht-Airport, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,Technomed Europe·cleared 2013-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.