FDAnews
www.fdanews.com/articles/168081-zoll-warned-after-inappropriate-shocks-with-medical-life-vest

Zoll Warned After Inappropriate Shocks With Medical Life Vest

October 24, 2014

The FDA has cited Zoll Manufacturing for failing to adequately validate its Class III medical Life Vest, noting that “approximately half of all treatments delivered to patients are inappropriate shocks,” according to a recent warning letter.
Devices & Diagnostics Letter