AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
FDA Recall Z-0658-2013 · Posted 2013-01-09
Advertisement
Recalling FirmZoll Circulation, Inc.
Recall StatusTerminated
Product CodeDRM
Date Initiated2012-08-08
Date Terminated2014-05-12
Product Quantity3881 in US, 1846 ROW.
Reason for Recall
Complaints associated with an unexpected stop in AutoPulse compressions.
Firm Action
Zoll sent Customer Notification letters dated August 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Zoll Technical Support Line at 1 (800) 348-9011 for further assistance.
Root Cause
Employee error
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K063602AUTOPULSE RESUSCITATION SYSTEM MODEL100Zoll Circulation · 2006-12-21K040453AUTOPULSE RESUSCITATION SYSTEM, MODEL 100Revivant Corp. · 2004-03-11K032852MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100Revivant Corp. · 2003-11-12K022345AUTOPULSE RESUSCITATION SYSTEMRevivant Corp. · 2002-08-15K011046AUTOPULSE, MODEL 100Revivant Corp. · 2001-10-25
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement