Z-0670-2007

Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient...

Name: Z-0670-2007 Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient...
Creator: Intuitive Surgical, Inc.
Published: 2006-04-12
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2006-04-12 / Terminated

FDA source

Intuitive Surgical, Inc. began a recall of Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01... on 2006-04-12. The reason FDA records is "Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0670-2007
Status: Terminated
Initiated: 2006-04-12
Posted: 2007-03-29
Terminated: 2007-12-05
Recalling firm: Intuitive Surgical, Inc.
Product: Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.
FDA root cause: Other
Action: The firm did not release notification to its consignees. The reworks were arranged as part of routine service visits initiated on 4/12/06.
Quantity in commerce: 24 units
Distribution: Nationwide.
Product codes and lots: System Numbers: SG011, SG012, SG013, SG014, SG017, SG018, SG019, SG020, SG058, and SG094.

Product code NAY

K050369Class IIIntuitive Surgical Da Vinci Surgical System, Model Is2000Intuitive Surgical, Inc. / cleared 2005-04-29

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)