FDA Device recall Z-1961-2020
da Vinci X Surgical System
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of da Vinci X Surgical System by Intuitive Surgical, citing due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1961-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-21 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intuitive Surgical |
| Distribution | CA, DE, FL, IL, KY, MA, MD, MI, NJ, NY, OH, TX, VA |
Product
da Vinci X Surgical System
Reason
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Identifiers
| code_info | Model: IS4200 UDI: 00886874114216 Device Listing: D295931 |
|---|
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-1961-2020%22
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