Events

Recall of DatexOhmeda TruSat

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ge Healthcare, Llc.

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
    55405
  • Event Risk Class
    Class 2
  • Event Number
    Z-1814-2010
  • Event Initiated Date
    2010-04-29
  • Event Date Posted
    2010-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90768
  • 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
    pulse oximeter - Product Code DPZ
  • Reason
    Ge healthcare has recently become aware that the trusat pulse oximeter with external power supply does not comply with current safety standards. it is possible that the external power supply could leak electrical current. this current could cause third degree burns or an abnormal heart rhythm that, if untreated, could lead to death.
  • Action
    Consignees were sent on 4/29/10 a GE Healthcare "Urgent Medical Device Correction" letter dated 4/22/10. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing, Director of Biomedical Engineering, and Home Healthcare Provider. The letter included the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information.

Device

DatexOhmeda TruSat
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BANGLADESH,BELGIUM, BOLIVIA, BRAZIL, CANADA, INDIAN OCEAN TERRITORY, CHILE COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON LIBYAN ARAB JAMAHIRYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MEXICO, MOZAMBIQUE, NEPAL, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM, ZAMBIA.
  • Product Description
    DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
  • Manufacturer
    Ge Healthcare, Llc

Manufacturer

Ge Healthcare, Llc
  • Manufacturer Address
    Ge Healthcare, Llc, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA