Events

Recall of Patient Side Cart Battery Box

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
    68593
  • Event Risk Class
    Class 2
  • Event Number
    Z-1994-2014
  • Event Initiated Date
    2012-04-27
  • Event Date Posted
    2014-07-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128285
  • 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
    System,surgical,computer controlled instrument - Product Code NAY
  • Reason
    Patient side cart battery boxes may overheat in rare charging conditions, causing battery bulging.
  • Action
    No notification was sent. Issue is being addressed during routine maintenance or through complaint process.

Device

Patient Side Cart Battery Box
  • Model / Serial
    Material number 371268-02 - al lots.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. || Intuitive Surgical Inc. || Sunnyvale, CA 94086
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Manufacturer Parent Company (2017)
    Intuitive Surgical Inc
  • Source
    USFDA