Z-0845-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- October 23, 2018
- Termination Date
- January 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 PSCs (Units)
Product Description
The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.
Reason for Recall
The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.
Distribution Pattern
Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.
Code Information
The Affected Systems are : SP0022, SP0023, SP0024, SP0025 and SP0026.