Z-1048-2015Class II

da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the...

Name: Z-1048-2015 da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the...
Creator: Intuitive Surgical, Inc.
Published: 2015-01-15
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2015-01-15 / Terminated / root cause: labeling and UDI

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic... on 2015-01-15. FDA classified it as Class II and gives the reason as "The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1048-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-15
Posted: 2015-02-03
Terminated: 2015-03-03
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Medical Device Recall Replacement letters were sent to all customers on January 15, 2015. The letter identified the reason for the recall, the risk to health, affected products, and actions to be taken by the customer or user and the firm. Customers were asked to discard the existing EndoWrist Stapler Documentation and replace it with the new Documentation provided by the firm. Intuitive Surgical will ship replacement instruments at no charge to customers. Then customers were asked to reunite the replacement instruments with the additional components. The firm will retrain customers on the updated instructions for use. A Clinical Sales Representative or Intuitive Surgical Customer Service at 1-800-876-1310, should be contacted if further information or support is needed concerning the recall notification.
Quantity in commerce: 1,034
Distribution: Nationwide Distribution
Product codes and lots: PN 410298-05, -06, -07, -08, -09

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1048-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1048-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-03

Product code NAY

K123463Class IIIntuitive Surgical Da Vinci Si Surgical System SmartpedalsIntuitive Surgical, Inc. / cleared 2012-12-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)