Recall Z-1904-2011 ยท DRM Compressor, Cardiac, External
Zoll Circulation, Inc.
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.
| Date | Apr 7, 2011 (initiated Jan 28, 2008) |
| Status | Terminated |
| Reason | Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions). |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072527 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 Zoll Circulation, Mar 19, 2008 |