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