Recall Z-3206-2011 ยท DPZ Oximeter, Ear
GE Healthcare, LLC
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare)
| Date | Sep 14, 2011 (initiated Apr 8, 2011) |
| Status | Terminated |
| 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). |
| Root cause | Device Design |
| 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. |
| Quantity | 31,846 |
| 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 A |
| 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 |