Z-2131-2020Class II

da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery

Name: Z-2131-2020 da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery
Creator: Intuitive Surgical, Inc.
Published: 2019-08-19
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2019-08-19 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery on 2019-08-19. FDA classified it as Class II and gives the reason as "Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2131-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-08-19
Posted: 2020-06-01
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Medical Device Recall Letters (Field Safety Notices) were hand-delivered to U.S. customers on August 19, 2019 and OUS customers on August 20, 2019. Customers were asked to locate affected camera(s) in their inventory and inspect per the instructions attached to the Field Safety Notice throughout the life of the camera(s). If residual soil is present, customers were to return the affected camera(s) to the manufacturer using the standard Return Materials Authorization (RMA) process. Additionally, customers were requested to: iInform necessary hospital personnel about this issue; complete the attached Acknowledgement Form and return it via fax to Intuitive as instructed on the form; and to retain a copy of this letter and the Acknowledgement Form for their files. Customers were informed that an Intuitive Representative would schedule a site visit to review the attached inspection instructions, and that the firm will provide a replacement camera, at no charge, for returned affected product. Customers requiring further information or support may contact their Clinical Sales Representative or contact Intuitive Customer Service at the following numbers: US Customer Service (800) 876-1310, Option 3 (7 AM to 5 PM EST) or [email protected], or South Korea Customer Service: + 82-02-3271-3200, Option 3 ( 9AM to 6 PM KSTJ)
Quantity in commerce: 305 units
Distribution: Distribution US nationwide and South Korea.
Product codes and lots: Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2131-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2131-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-26

Product code NAY

K173906Class IIda Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. / cleared 2018-05-31

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)