Events

Recall of Device Recall CAS Medical Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CAS Medical Systems, 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
    29223
  • Event Risk Class
    Class 2
  • Event Number
    Z-1023-04
  • Event Initiated Date
    2004-05-24
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33356
  • 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
    Monitor, Breathing Frequency - Product Code BZQ
  • Reason
    Device may not alarm for %spo2 value limit violations if a specific feature is enabled.
  • Action
    CAS Medical notified customers by telephone and followed with letter dated 5/24/04, advising users of the problem and to turn off the StatsSeconds feature.

Device

Device Recall CAS Medical Systems
  • Model / Serial
    Serial Numbers:  0351320- through 0351369, 0413101through 0413107, 0413109,through 0413117, 0413119 through 0413125, 0413188, 0413452 through 0413501 through 0414477.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, DC, IL, IN, GA, ME, MI, MN, NH, NJ, NY, PA, TX, WV. Foreign: Canada, Taiwan
  • Product Description
    Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
  • Manufacturer
    CAS Medical Systems, Inc.

Manufacturer

CAS Medical Systems, Inc.
  • Manufacturer Address
    CAS Medical Systems, Inc., 44 E Industrial Rd, Branford CT 06405-6507
  • Source
    USFDA