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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:137832

INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Official recall number

Z-1949-2015

Evidence summary

Product code
NAY
Recall status
Terminated
Event initiated
June 16, 2015
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1949-2015

Field note

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