Events

Recall of DATEXOHMEDA TRUSAT PULSE OXIMETER

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
    57889
  • Event Risk Class
    Class 2
  • Event Number
    Z-3206-2011
  • Event Initiated Date
    2011-04-08
  • Event Date Posted
    2011-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97686
  • 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
    The plastic enclosure on the external power supply of the trusat pulse oximeter is prone to breakage, and overheating. the issue may impact patient or user safety. potential for system or components to start on fire or explode (general case).
  • Action
    On 4/8/11 GE Healthcare sent consignees an "Urgent Medical Device Correction" letter dated March 30, 2011. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, Director of Biomedical Engineering & Home Healthcare Provider. The letter listed the Safety Issues, Safety Instructions, Affected Product Details, Product Correction and Contact Information.

Device

DATEXOHMEDA TRUSAT PULSE OXIMETER
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, ZAMBIA, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UGANDA, TURKEY, TUNISIA, TRINIDAD & Tobago, THAILAND, UNITED REPUBLIC OF TANZANIA, PROVINCE OF CHINA TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SUDAN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, OMAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, NEPAL, MOZAMBIQUE, MEXICO, MALTA, MALAYSIA, MACEDONIA, LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HUNGARY, HONG KONG, HONDURAS, GUATEMALA, GUADELOUPE, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, KOREA, EL SALVADOR, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, COSTA RICA, COLOMBIA, CHINA, CHILE , CANADA, BRITISH INDIAN OCEAN TERRITORY, BRAZIL, BOLIVIA, BENNIN, BELGIUM, BANGLADESH, BAHAMAS, AUSTRIA, AUSTRALIA, ARGENTINA, and ALGERIA.
  • Product Description
    DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare)
  • 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