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Technomed Europe recalls Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Recalled September 21, 2022 · FDA recall Z-1737-2022 · Technomed Europe
Hazard
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. · FDA Class II
Units
37/25-electrode boxes
Sold at
US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
Description
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.
Product
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Manufacturer(s)
Technomed Europe
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →