Z-0283-2021Class II

da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is...

Name: Z-0283-2021 da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is...
Creator: Intuitive Surgical, Inc.
Published: 2019-06-17
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2019-06-17 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number... on 2019-06-17. FDA classified it as Class II and gives the reason as "One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0283-2021
Classification: Class II
Status: Terminated
Initiated: 2019-06-17
Posted: 2020-10-23
Terminated: 2022-07-18
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Send formal customer letter communication to the affected site. The firm reported that a representative scheduled an on-site visit to replace the affected unit.
Quantity in commerce: 1 system
Distribution: US Nationwide distribution including in the state of Washington.
Product codes and lots: IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0283-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0283-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-23

Product code NAY

K131861Class IIDa Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. / cleared 2014-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)