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Terminated

DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare)

FDA Recall Z-3206-2011 · Posted 2011-09-14

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeDPZ
Date Initiated2011-04-08
Date Terminated2016-03-04
Product Quantity31,846

Reason for Recall

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).

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040831DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc. · 2004-09-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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