FDA has issued another update to a previous voluntary recall of Asahi Kasei (TYO:3407) subsidiary Zoll Medical‘s LifeVest 4000 wearable automatic external defibrillators following two patient deaths.
In January and July 2018, the agency and the company advised patients to contact Zoll immediately for a replacement if their device displays the message: “Call for Service—Message Code 102.” The alert indicates that the vest may have an electrical issue that causes it to fail to deliver an electrical shock to restore the patient to a normal heart rhythm.