Intuitive Surgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1048-2015)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2015.
Data Source: FDA.
Product Description:
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 Classification:
Class II
Date Initiated: January 15, 2015
Date Posted: February 11, 2015
Recall Number: Z-1048-2015
Event ID: 70181
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.
Status: Terminated
Product Quantity: 1,034
Code Information:
PN 410298-05, -06, -07, -08, -09
Distribution Pattern:
Nationwide Distribution
Voluntary or Mandated:
Voluntary: Firm initiated