The affected components are used for audiological, neurological or vestibular testing. The devices include cables that may be red, orange, yellow, green, blue, brown, black or white, according to the safety notice out of the U.K.
Natus Medical said the electrode lead connector in the affected devices has a conductive surface that protrudes beyond the insulation by approximately 0.1 mm, which is not compatible with the applicable electrical safety standards.
The Pleasanton, Calif.–based company instructed users to identify and quarantine affected devices and report suspected or actual adverse events involving them.
The safety notice was for all of the United Kingdom. Natus Medical set the deadline to take action for Jan. 7, 2020, and to complete actions on Jan. 21, 2020.
Natus Medical develops medical equipment, software, supplies and services for diagnosing, monitoring and treating impairments and disorders affecting newborns, the brain, nerves, muscles, balance, mobility and hearing, according to the company’s website.