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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:126742

100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Official recall number

Z-1687-2015

Evidence summary

Product code
DTQ
Recall status
Terminated
Event initiated
May 01, 2015
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1687-2015

Field note

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