Events

Recall of Device Recall TeleSentry

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

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
    73381
  • Event Risk Class
    Class 2
  • Event Number
    Z-1315-2016
  • Event Initiated Date
    2016-02-25
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143993
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Reason
    The firm received a complaint of the battery exploding while recharging.
  • Action
    On 2/26/2016 the firm sent "Urgent: TeleSentry Battery Recall" notification letters to their customers. The letter identified the affected device and the reason for the recall. Customers were asked to immediately examine their inventory and quarantine the affected device. If the product had been further distributed, then a copy of the letter should be provided to those customers. Customers are to follow the steps provided for returning the affected device, including contacting ScottCare Service at 1-800-243-9412. In addition, the attached response form should be completed and returned. Questions should be directed to ScottCare Customer Service at 1-800-243-9412.

Device

Device Recall TeleSentry
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of CA, CT, DE, FL, IL, KS, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, & WV; and, the country of Canada.
  • Product Description
    TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. || Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia.
  • Manufacturer
    Scottcare Corporation

Manufacturer

Scottcare Corporation
  • Manufacturer Address
    Scottcare Corporation, 4791 W 150th St, Cleveland OH 44135-3301
  • Manufacturer Parent Company (2017)
    Berkshire Hathaway Inc
  • Source
    USFDA