Events

Recall of Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver.

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

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
    35391
  • Event Risk Class
    Class 2
  • Event Number
    Z-1202-06
  • Event Initiated Date
    2006-05-05
  • Event Date Posted
    2006-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45982
  • 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
    Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.
  • Action
    On May 5, 2006 a letter was issued to all consignees, via return receipt requested. The letter advised consignees of the issue and provided some ways to mitigate the risk. Anyone experiencing the anomaly is to document the failure and report it to the firm. A field service representative will visit each consignee to optimize the antenna system to reduce intermodulations. After determining the root cause and validating a fix, the firm issued a second letter dated August 21, 2006 to their consignees. The letter advised consignees of three issues that needed 'improvement' and stated a service engieneer will schedule a time to visit and install the improvements.

Device

Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Mode...
  • Model / Serial
    All systems - each major component has its own serial number
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The systems were distributed to 22 hospitals/medical centers nationwide and to 2 Spacelabs personnel. There is no international distribution.
  • Product Description
    Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver.
  • Manufacturer
    Spacelabs Medical Incorporated

Manufacturer

Spacelabs Medical Incorporated
  • Manufacturer Address
    Spacelabs Medical Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA