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.
Reported: May 6, 2020 Initiated: March 30, 2020 #Z-1798-2020
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 146,633
- Distribution
- Worldwide distribution - US Nationwide and Global distribution.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 146,633.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1798-2020.
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