FDAFDA · Food and drugs·Recall number Z-0658-2013
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.
Published January 16, 2013 · Recall initiated: August 8, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints associated with an unexpected stop in AutoPulse compressions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zoll Circulation, Inc.
- Distributor
- Worldwide distribution.
- Lot
- all
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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