Events

Recall of Device Recall ISite PACS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stentor 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
    34270
  • Event Risk Class
    Class 2
  • Event Number
    Z-0399-06
  • Event Initiated Date
    2005-12-20
  • Event Date Posted
    2006-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43397
  • 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, Image Processing, Radiological - Product Code LLZ
  • Reason
    When using a third party dictation accessory with the isite pacs, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens.
  • Action
    On 12/20/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.

Device

Device Recall ISite PACS
  • Model / Serial
    All models, version 3.3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
  • Manufacturer
    Stentor Inc

Manufacturer

Stentor Inc
  • Manufacturer Address
    Stentor Inc, 5000 Marina Blvd, Brisbane CA 94005-1330
  • Source
    USFDA