Intuitive Surgical, Inc.: System, Surgical, Computer Controlled Instrument
Recall Summary Intuitive Surgical is recalling the near-infrared handheld camera (called SOCK) used with da Vinci 5 surgical systems because the camera can unintentionally turn on when surgeons are trying to turn off its light during normal workflow transitions, such as when switching from the handheld camera to the robotic endoscope. The affected systems have been distributed across the United States, Puerto Rico, and multiple countries including Australia, Japan, South Korea, and several European nations. This is classified as a Class II recall, indicating a potential health risk but not an immediately life-threatening situation.
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for...
- Reason
- Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, ...
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, New Zealand,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/9b8a934c-3a14-480f-aede-db4a7e0764ea