Events

Recall of Device Recall daVinci S Surgical System IS2000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intuitive Surgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38301
  • Event Risk Class
    Class 2
  • Event Number
    Z-1245-2007
  • Event Initiated Date
    2007-05-14
  • Event Date Posted
    2007-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53366
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    endoscopic instrument control system - Product Code NAY
  • Reason
    Product may malfunction and fail to start up on ac power.
  • Action
    As of 9/12/2007, the firm has conducted a field inspection of any involved units via service visit. No other notice is planned or indicated by the firm's submission. The firm feels that the risk associated with this issue is minimal, and therefore, any advanced notification is unneccessary. If any system failed one or more of the inspection points, its APB (3510404-04) was replaced with a verified APB (351040-04 or 351040-05).

Device

Device Recall daVinci S Surgical System IS2000
  • Model / Serial
    Model number IS2000, part number 351040-04. System numbers SG002, SG004, SG010 , SG032, SG060, SG061, SG064, SG065, SG066, SG067, SG068, SG069, SG070, SG071, SG072, SG073, SG074, SG075, SG076, SG077, SG078, SG079, SG080, SG081, SG082, SG083, SG084, SG086, SG090, SG116, SG117, SG118, SG120, SG121, SG126, SG174, SG175, SG184
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore.
  • Product Description
    daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 950 Kifer Rd, Sunnyvale CA 94086-5206
  • Source
    USFDA