FDA Device recall Z-0845-2020
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)…
- FDA Device
- Class II
- terminated
- Published 2020-02-05
On 2020-02-05 the FDA classified a Class II recall of 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)… by Intuitive Surgical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0845-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-23 |
| Published | 2020-02-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intuitive Surgical |
| Distribution | MN, NY, OH, PA |
Product
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
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.
Identifiers
| code_info | The Affected Systems are : SP0022, SP0023, SP0024, SP0025 and SP0026. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0845-2020%22
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