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

Recall Z-2218-2019 — The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contain

U.S. FDA — Device Enforcement · United States · 2018-02-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2218-2019
Date of alert: 2018-02-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ra Medical Systems Inc
Product category: device
Product type: Devices

Reported risk: Lasers/Catheters did not calibrate during set-up prior to use.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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