medical Class II Updated 2019-09-04

Ad-Tech Medical Instrument Corporation recalls Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micr

Recalled Product

Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes


Hazard / Issue

Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All catalog numbers and lot numbers distributed through May 30, 2019
View official government recall

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