Class I - Dangerous
Product has have presence of brown discoloration or substance on the hinge area of the device
Technomed Europe
Class I - Dangerous
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.
Class I - Dangerous
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.