Events

Recall of Device Recall General Purpose Temperature Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Signs Devices, a GE Healthcare Company.

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
    65857
  • Event Risk Class
    Class 2
  • Event Number
    Z-1959-2013
  • Event Initiated Date
    2013-07-18
  • Event Date Posted
    2013-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120513
  • 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
    Thermometer, electronic, clinical - Product Code FLL
  • Reason
    Ge healthcare has become aware of a potential safety issue associated with the use of ge general purpose 9 french temperature probe, disposable, 400 series [m1024229]. ges disposable general purpose 9fr temperature probe m1024229 is intended for oro-esophageal and rectal use. as it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe.
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 23, 2013 via Fed Ex beginning on July 29, 2013 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE will update the Instructions for Use (IFU) and pouch label with new content related to insertion locations. GE has will also place the probe (M1024229) on quality hold until the new labeling changes are implemented. If you have any questions or concerns regarding this notification, please contact GEMSIT Customer Service at 1-800-588-7044 (Domestic) or Vital Signs Customer Service at 1-800-932-0760 (international). Hours of operation: 8:00 am EST to 6:00 pm EST.

Device

Device Recall General Purpose Temperature Probe
  • Model / Serial
    GE product number M1024229
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kingdom.
  • Product Description
    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. || Continuous temperature monitoring.
  • Manufacturer
    Vital Signs Devices, a GE Healthcare Company

Manufacturer

Vital Signs Devices, a GE Healthcare Company
  • Manufacturer Address
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA