Recall Z-1814-2010 ยท DPZ Oximeter, Ear
Ge Healthcare, Llc
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
| Date | Jun 22, 2010 (initiated Apr 29, 2010) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| 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. |
| Quantity | 28,442 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040831 | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 Datex-Ohmeda, Inc., Sep 2, 2004 |