Data Foundry

Medical device recalls 2020

da Vinci X Surgical System Surgical System — Class II medical device recall Z-0926-2020

Terminated recall by Intuitive Surgical, Inc., reported 2020-02-12, distributed nationwide. The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi

Recall numberZ-0926-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIntuitive Surgical, Inc., Sunnyvale, CA, United States
Recall initiated2019-07-26
Classified2020-01-31
Reported by FDA2020-02-12
Terminated2022-08-10
DistributedNationwide (US)
Countries outside the USBE, BR, DE, ES, FR, GB, IE, IN, IT, JP, KR, MX, NO, PA, PL, TW
Quantity52 surgical
UPC / GTIN / UDI-DI00886874114216
Serial numbers665033, SL0350

Product

da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.

Reason for recall

The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0926-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.