FDA-Device2022-09-21Class II
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
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.
Sold states
US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
Affected count
37/25-electrode boxes
Manufactured in
Amerikalaan 71, Maastricht-Airport, Netherlands
Products
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1737-2022Don't want to check this manually?
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