Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.
FDA Recall Z-1904-2011 · Posted 2011-04-07
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Recalling FirmZoll Circulation, Inc.
Recall StatusTerminated
Product CodeDRM
Date Initiated2008-01-28
Date Terminated2011-04-28
Product Quantitynot provided
Reason for Recall
Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).
Firm Action
The firm, Zoll Circulation Inc., initiated a Corrective and Preventive Action Report on January 28, 2009. According to the firm, the customers were contacted by telephone calls and were provided with a Battery Maintenance program. For further questions you may call (408) 541-2140 ext.341.
Root Cause
Other
Distribution Pattern
Nationwide Distribution -- including, VA, NY, OH, IN, MO, UT, FL, NC, ME, WA, SD, NM, PA, MS, ID, TX, GA, CA, CO, IL, AR, WV, TN, OR, and KS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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