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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:140703

Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.

Official recall number

Z-0320-2016

Evidence summary

Product code
MKJ
Recall status
Terminated
Event initiated
October 14, 2015
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0320-2016

Field note

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