Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Reported: December 6, 2023 Initiated: October 6, 2023 #Z-0406-2024
Product Description
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Reason for Recall
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 317 units
- Distribution
- US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm. Recalled by Intuitive Surgical, Inc.. Units affected: 317 units.
Why was this product recalled? ▼
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 6, 2023. Severity: Moderate. Recall number: Z-0406-2024.
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