Events

Recall of Device Recall Gamma X XL Portable Patient Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger 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
    59568
  • Event Risk Class
    Class 2
  • Event Number
    Z-3048-2011
  • Event Initiated Date
    2011-07-29
  • Event Date Posted
    2011-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103117
  • 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
    Physiological Patient Monitor (with Arrhythmia Detection or Alarms) - Product Code MHX
  • Reason
    Monitor keys may spontaneously become inoperative or active. this may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
  • Action
    Draeger Medical sent an "Urgent Medical Device Recall Notification" letters dated July 2011 to all affected customers. The letter included product and problem affected. The letter informed the customer a Draeger representative will contact them to upgrade the system. Until the solution is implemented, Draeger recommends the Delta and/or Gamma XXL may be used. If the affected monitors become inoperative or activate without user interaction, Draeger advises removing the monitor from service and contacting a Draeger representative. For questions or for information on this recall please call Draeger Service at (800) 543-5047 (press 1 at the prompt, then 2, then 32349).

Device

Device Recall Gamma X XL Portable Patient Monitor
  • Model / Serial
    Catalog Number(s): MS18597/MS18852 with serial numbers (US) 6001246076, 6001246575, 6001247173, 6001365874, 6001067474, 6001073681, 6001073779, 6001073877, 6001095176, 6001098966, 6001099466, 6001069472, 6001077080, 6001198466, 6001216679, 6001229674, 6001208082, 6001211782, 6001218178, 6001220086, 6001243676, 6001246771, 6001245968, 6001357179, 6001214877, 6001075679, 6001077178, 6001083180, and 6001095773.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - (USA) Nationwide distribution including the states of AK, FL, LA, MN, MS, MO, NJ, NC, OH, OK, PA, TN, TX, NC, NH, NJ, NY, WV, and WI; and the countries of Australia, Austria, Argentina, Bahrain, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Georgia, Greece, Hungary, Italy, Ireland, India, Kazakhstan, Latvia, Macedonia, Malaysia, Mexico, Netherlands, Norway, Russian Fed., Romania, Saudi Arabia, Slovakia, Spain, South Africa, Switzerland, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.
  • Product Description
    Infinity Gamma X XL Portable Patient Monitor. || Draeger Medical Systems, Inc. || Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
  • Manufacturer
    Draeger Medical Systems, Inc.

Manufacturer

Draeger Medical Systems, Inc.
  • Manufacturer Address
    Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA