ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.

Failure of Device to display ECG could delay delivery of defibrillation or pacing therapy.

Zoll notified domestic consignees on August 31, 2009 and international consignees on September 1, 2009 by an Urgent Medical Device Correction letter. Customers were instructed to continue to perform daily tests per the recommendations provided in the R Series Operator's Guide. In the event of a failure, customers are to remove the device from service and contact biomedical or clinical engineering department per their facility's protocol. Units that operate as expected can remain in service and back-up monitor should be available in the event of a failure. Zoll's technical support department should be contacted at 1-800-348-9011 or +1-978-421-9460 to schedule the return of affected devices with the defect for replacement of the suspect component.