Z-1811-2008

INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part...

Name: Z-1811-2008 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part...
Creator: Intuitive Surgical, Inc.
Published: 2008-04-18
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2008-04-18 / Terminated / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and... on 2008-04-18. The reason FDA records is "The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1811-2008
Status: Terminated
Initiated: 2008-04-18
Posted: 2008-09-17
Terminated: 2011-03-25
Recalling firm: Intuitive Surgical, Inc.
Product: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.
Root cause tag: software
FDA root cause: Software design
Action: On April 18, 2008 an Urgent Device Recall letter was issued to customers. Consignees were notified via e-mail and were instructed to return the product. Customers were instructed to segregate the product in a secure area for Intuitive Surgical CSRs. If you have any questions contact Karen Uyesugi at (408) 523-2100.
Quantity in commerce: 11
Distribution: Class II Recall - Nationwide Distribution --- including states of NC, OH, GA and WI.
Product codes and lots: Lot Number: 802011

Product code NAY

K070947Class IIIntuitive Surgical Da Vinci Surgical System and Endoscopic Instruments and Endowrist Cardiac Probe GrasperIntuitive Surgical, Inc. / cleared 2008-02-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)