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
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