Events

Recall of Device Recall Ultraview SL Capnography Module, Model 91517

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
    32815
  • Event Risk Class
    Class 2
  • Event Number
    Z-0517-06
  • Event Initiated Date
    2005-07-20
  • Event Date Posted
    2006-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40875
  • 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
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - Product Code CCK
  • Reason
    The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. the module will not compensate for pressure changes and co2 readings will be inaccurate at higher altitudes.
  • Action
    On 7/20/05 Spacelabs called the consignees that received the units to notify them of the hazard and also the schedule a service call to repair the affected capnography modules. The firm will confirm that all consignees have been updated with the appropriate PCBA and will audit the device recall records for completion.

Device

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.
  • Manufacturer
    Spacelabs Medical Incorporated

Manufacturer

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