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

Recall Z-1798-2020 — MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

U.S. FDA — Device Enforcement · United States · 2020-03-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1798-2020
Date of alert
2020-03-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
21857621
Reported risk: To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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