Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0050-2021 — DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.

U.S. FDA — Device Enforcement · United States · 2020-07-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0050-2021
Date of alert
2020-07-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ra Medical Systems, Inc.
Product category
device
Product type
Devices
Reported risk: Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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