Manufacturers

Spacelabs Medical Incorporated

5 devices in the database

BirthNet
  • Model / Serial
    All serial numbers involved
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was to 44 medical facilities/hospitals nationwide.
  • Product Description
    BirthNet OB Data Management System 91861
Tru-Link DIN unshielded ECG cable, 5-lead
  • Model / Serial
    Lot codes: 31942, 34956, 35209, 35296, 35747, 36239, 36555 Part number: 012-0123-01
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Cables were distributed to 9 US hospitals/medical centers and 30 international customers.
  • Product Description
    Tru-Link DIN unshielded ECG cable, 5-lead
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.
Device Recall Ultraview SL Capnography Module, Model 91517
  • Model / Serial
    Model 91517 Lot BMP007559
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    8 units shipped to France, 1 unit to Brussels, Belgium, and 2 units to a medical center in WY.
  • Product Description
    Ultraview SL Capnography Module, Model 91517 || A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ventilatory, circulatory, and metabolic status.
Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385
  • Model / Serial
    Universal Ultraview Clinical Workstation Model 90385 base versions with Revision M or earlier. This recall involves certain units within the serial number range SN: 385-000337 to SN: 385-111440. The firm indicated that not all serial numbers within this range are affected by this recall, but only those units with the specified Revision M or earlier base which have not already been updated.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm completed a survey of their customer records and determined a total of 12,306 units were installed from January of 1994 through December of 1997. 7,601 units were originally sold to 767 US accounts and 4,705 units were sold to 102 international accounts. The firm estimates approximately 3000 units worldwide are still in operation with the Revision M or earlier base.
  • Product Description
    Ultraview Universal Clinical Workstation System Model 90385.