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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:112116

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.

Official recall number

Z-0658-2013

Evidence summary

Product code
DRM
Recall status
Terminated
Event initiated
August 08, 2012
Root cause
Employee error
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0658-2013