Z-0845-2020 Class II Terminated
FDA device recall Z-0845-2020 was initiated by Intuitive Surgical, Inc. on Oct 23, 2018 and is designated Class II. 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. The recall status is terminated (terminated Jan 21, 2022). Affected quantity: 5 PSCs (Units).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 5, 2020
- Initiation Date
- Oct 23, 2018
- Termination Date
- Jan 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0845-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026