Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1904-2011

Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as...

ZOLL Circulation, Inc. / initiated 2008-01-28 / Terminated

Zoll Circulation, Inc. began a recall of Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is... on . The reason FDA records is "Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions)". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1904-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ZOLL Circulation, Inc.
Product
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.
Product code
DRM Compressor, Cardiac, External
Reason for recall
Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).
FDA root cause
Other
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.
Quantity in commerce
not provided
Distribution
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.
Product codes and lots
Model 100; AutoPulse product number 8700-0700-xx AutoPulse 1.5G; AutoPulse Battery Part Number 8799-0702-xx