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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:183111

DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.

Official recall number

Z-0050-2021

Evidence summary

Product code
PDU
Recall status
Terminated
Event initiated
July 24, 2020
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0050-2021