PlainRecalls
FDA Devices Moderate Class II Terminated

AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

Reported: January 16, 2013 Initiated: August 8, 2012 #Z-0658-2013

Product Description

AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

Reason for Recall

Complaints associated with an unexpected stop in AutoPulse compressions.

Details

Recalling Firm
Zoll Circulation, Inc.
Units Affected
3881 in US, 1846 ROW.
Distribution
Worldwide distribution.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.. Recalled by Zoll Circulation, Inc.. Units affected: 3881 in US, 1846 ROW..
Why was this product recalled?
Complaints associated with an unexpected stop in AutoPulse compressions.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 16, 2013. Severity: Moderate. Recall number: Z-0658-2013.