ClearanceBrief
Recall Z-2090-2014 ยท DRM Compressor, Cardiac, External

Zoll Circulation, Inc.

Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest

DateJul 22, 2014 (initiated Jul 16, 2013)
StatusTerminated
ReasonTypographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product.
Root causeLabeling Change Control
ActionZoll Japan handled the recall.
Quantity161 Nickel Metal batteries, 40 LifeBand
DistributionDistributed in Japan.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K011046AUTOPULSE, MODEL 100
Revivant Corp., Oct 25, 2001
K022345AUTOPULSE RESUSCITATION SYSTEM
Revivant Corp., Aug 15, 2002
K032852MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
Revivant Corp., Nov 12, 2003
K040453AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
Revivant Corp., Mar 11, 2004