Events

Recall of TCm monitoring system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America 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
    35696
  • Event Risk Class
    Class 3
  • Event Number
    Z-1453-06
  • Event Initiated Date
    2006-04-07
  • Event Date Posted
    2006-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46636
  • 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
    Monitoring system - Product Code KLK
  • Reason
    System shut down-when the tcm monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.
  • Action
    The firm began a recall/corrective action in response to this component defect on 4/7/2006, at which time, the firm issued a Field Action Notes memo (915-234). The firm is having their representatives: 1) assure that the use of the CompactFlashcards manufactured by Simple Tech has been discontinued at each customer location; 2) Replaace the CompactFlash card in all basic Units, 391-876, of R0036 through R0043; and 3) replace any spare part #914-698, which has been installed in Basic Units, 391--876, below R0036. Once completed, the firm has supplied their customers with a TELEFAX form to be completed, signed and dated by each customerand faxed back to Radiometer Medical ApS. The form documents that the instructions provided in theField Action Notes have been followed and that the necessary component replacements have been completed. The firm anticipates that the necesary corrective action will be completed by 7/1/2006.

Device

TCm monitoring system
  • Model / Serial
    TCM4 - Base Unit : Model: 391-876, Lot Numbrs R0036 thru R0043 (both inclusive). CompactFlash cards - Component: Model #914-698
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-The recalled product was distributed to customers throughout the U.S. and Canada.
  • Product Description
    TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA