Z-0283-2021 Class II Terminated
FDA device recall Z-0283-2021 was initiated by Intuitive Surgical, Inc. on June 17, 2019 and is designated Class II. Reason for recall: One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperatu… The recall status is terminated (terminated July 18, 2022). Affected quantity: 1 system.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- June 17, 2019
- Termination Date
- July 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 system
Product Description
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Reason for Recall
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
Distribution Pattern
US Nationwide distribution including in the state of Washington.
Code Information
IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137