Events

Recall of Device Recall Cisco

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cisco Systems 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
    62770
  • Event Risk Class
    Class 2
  • Event Number
    Z-2263-2012
  • Event Initiated Date
    2012-07-23
  • Event Date Posted
    2012-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111681
  • 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
    Software transmission and patient data storage medical - Product Code NSX
  • Reason
    Software anomaly may result in incorrect values and interpretations. the initial vital signs reading will display accurately on the cisco health presence vitals tab and the oneplace tab. however, subsequent vital signs readings will only update on the cisco healthpresence vitals tab and within the oneplace database, but will not update under the oneplace tab, and thus, will not provide current vit.
  • Action
    Cisco notified their one customer by phone on July 25, 2012, with a follow up email and instructed the customer to stop using the OnePlace vitals tab and to use the CHP only. On July 27th, 2012, the vendor of the OnePlace application, fixed the bug remotely. On July 31, 2012, Cisco's staff physician contacted the customer to confirm that the customer was aware of the fix. Validation of the correction was completed by Cisco, along with customer on August 9, 2012. Until validation was satisfactorily completed, the integrated system lie dormant at customer's site.

Device

Device Recall Cisco
  • Model / Serial
    Serial/Code Number: 2.1.0.87
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the state of TN.
  • Product Description
    Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA || Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming.
  • Manufacturer
    Cisco Systems Inc

Manufacturer

Cisco Systems Inc
  • Manufacturer Address
    Cisco Systems Inc, 170 W Tasman Dr, San Jose CA 95134
  • Manufacturer Parent Company (2017)
    Cisco Systems Inc
  • Source
    USFDA