Recall Z-1904-2011
Zoll Circulation, Inc. · initiated January 28, 2008
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.
Codes / lots: Model 100; AutoPulse product number 8700-0700-xx AutoPulse 1.5G; AutoPulse Battery Part Number 8799-0702-xx
Reason for recall
Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1904-2011
- Initiated
- January 28, 2008
- Posted by FDA
- April 7, 2011
- Terminated
- April 28, 2011
- Product code
- DRM – Compressor, Cardiac, External
- Quantity
- 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.
- Recalling firm
- Zoll Circulation, Inc., Sunnyvale, CA