FDA recall Z-0406-2024

Intuitive Surgical, Inc. · Class II · device

Product

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.

Distribution

US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea

Key facts

Status
Ongoing
Initiation date
2023-10-06
Report date
2023-12-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0406-2024