Datex-Ohmeda Trusat Pulse Oximeter And Accessories…

Date posted by the FDA

June 22, 2010

Status

Terminated

Filed by

Ge Healthcare, Llc

Product

DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500

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.

Distribution pattern

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.

Quantity

28,442 units

Codes and lots

Parent SN max(30)[UM] FCC06240026SA FCC06330016SA FCC06330022SA FCC06330023SA FCC06330025SA FCC07170010SA FCC07440003SA FCC07440017SA FCC07440021SA FCC07440060SA FCC07440066SA FCC09070111SA FCC09070126SA FCD07100222SA FCD09440003SA FCD09440013SA FCD06160014SA FCC06240120SA FCC07100031SA FCC07100033SA FCD06430061SA FCD06470013SA FCDH00267 FCDH00276 FCF06310023SA FCF06400010SA FCC06230025SA FCC06230035SA FCC06230039SA FCC06230045SA FCC06230048SA FCC06420020SA FCC06420025SA FCC06420026SA FCC06420030SA FCC06420040SA FCC06420044SA FCC07140008SA FCC07140009SA FCC07140016SA FCC07140028SA FCC07140046SA FCC09280003SA FCC09280014SA FCD05300055SA FCD05300121SA FCD05300185SA FCD06240180SA FCD06360009SA FCD06360012SA FCD06360032SA FCD06360053SA FCD07340004SA FCD07380082SA FCD07420022SA FCD07420023SA FCD07420024SA FCD07420026SA FCD07420047SA FCD08050016SA FCD08050018SA FCD08050019SA FCD08050039SA FCD08370041SA FCD08370045SA FCD08370046SA FCD08370050SA FCD08370057SA FCD08370059SA FCD09160049SA FCD09160057SA FCD09160072SA FCD09160073SA FCD09160077SA FCDJ00806 FCDJ00812 FCDJ00832 FCD09200037SA FCDJ00066 FCD06240200SA FCD06280001SA FCD06280009SA FCD06280021SA FCD06290143SA FCD06400004SA FCD06410020SA FCD06410021SA FCD06430004SA FCC06250006SA FCC06370038SA FCC05230135SA FCC05410029SA FCC05420008SA FCC05480019SA FCC06170033SA FCC06170048SA FCC06410063SA FCC06410073SA FCC06420021SA FCC06430058SA FCC06430072SA FCC06440016SA FCC06440031SA FCC06440035SA FCC08300003SA FCC08300060SA FCC08310026SA FCC08310050SA FCC08320015SA FCC08330120SA FCC08360059SA FCC08440072SA FCC08440076SA FCC09080001SA FCC09080053SA FCC09080062SA FCC09080088SA FCC09500033SA FCCJ00736 FCD07140018SA FCD07140029SA FCD07330006SA FCD07330039SA FCD07380039SA FCD07380057SA FCD07470026SA FCD07470045SA FCD07470051SA FCD07470057SA FCD08050017SA FCD08050026SA FCD08080048SA FCD08080117SA FCD08110007SA FCD08120005SA FCD09190040SA FCD09200030SA FCD09200045SA FCD09210019SA FCD09210023SA FCD09210040SA FCD09210052SA FCD09220023SA FCD09240022SA FCD09240030SA FCD09240038SA FCD09260003SA FCD09260005SA FCD09260006SA FCD09260012SA FCC07080026SA FCC07190022SA FCC07190034SA FCC08500040SA FCC08500078SA FCD08370020SA FCD08370064SA FCC06020022SA FCC06120120SA FCC06120130SA FCC06170066SA FCC06190031SA FCC08290077SA FCC08290082SA FCC08290086SA FCC09100069SA FCC09100170SA FCD05320093SA FCD05320095SA FCD05470016SA FCD06230026SA FCD06230028SA FCD06230138SA FCD06280011SA FCD06280027SA FCD06280028SA FCD07370013SA FCD07370014SA FCD07370019SA FCD07370027SA FCD07370029SA FCD07380013SA FCD07380022SA FCD07380023SA FCD07380041SA FCD08080001SA FCD08080013SA FCD08080014SA FCD08080023SA FCD08080029SA FCD08080032SA FCD08080066SA FCD09170066SA FCD09170084SA FCD09180003SA FCE09160022SA FCE09300023SA FCE09500004SA FCE09500007SA FCE09500017SA FCE09500020SA FCD08330043SA FCC06330008SA FCC06340099SA FCC06370022SA FCC08030040SA FCC08030051SA FCC08030090SA FCD07140011SA FCD07170036SA FCD07180017SA FCD07240071SA FCD07240102SA FCD07240114SA…

Recall started

April 29, 2010

Device type

Oximeter, Ear

Root cause (FDA)

Component design/selection

What the company told customers

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.

Recall number

Z-1814-2010

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1814-2010. The agency record governs; check it and the company before acting.