Z-0845-2020Class II

The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart...

Name: Z-0845-2020 The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart...
Creator: Intuitive Surgical, Inc.
Published: 2018-10-23
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2018-10-23 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a 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). The Patient Cart... on 2018-10-23. FDA classified it as Class II and gives the reason as "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". 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-0845-2020
Classification: Class II
Status: Terminated
Initiated: 2018-10-23
Posted: 2020-01-24
Terminated: 2022-01-21
Recalling firm: Intuitive Surgical, Inc.
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.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 10/23/2018, the firm sent a "Medical Device Correction" Letter informing them about the cannula mount button issue and informing all personnel who are involved with da Vinci SP Surgery at their site of the following instructions. 1. Release the cannula mount button in a slow and controlled manner. This will prevent the button from snapping back potentially causing button damage. 2. If button damage occurs prior to procedure, discontinue use of the affected SP system. 3. If button damage occurs during a procedure, call dVSTAT for instructions to complete the procedure. ------------ 4. Complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for your files. The firm will: 1. Have a Surgical Representative schedule a site visit to repair your system as soon as possible. 2. Surgical representatives will be available by phone to answer any questions related to this Medical Device Correction. If you need further information or support concerning this Field Safety Notice, customer can contact their Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]. Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected]
Quantity in commerce: 5 PSCs (Units)
Distribution: Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.
Product codes and lots: The Affected Systems are : SP0022, SP0023, SP0024, SP0025 and SP0026.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0845-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0845-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24

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)