DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare)
FDA device recall Z-3206-2011 · posted 2011-09-14 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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).
- Action taken
- 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
- Status
- Terminated
- Product code
- DPZ
- Quantity affected
- 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 TAIW
- Date initiated
- 2011-04-08
- Date posted
- 2011-09-14
- Date terminated
- 2016-03-04
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (K040831) | Datex-Ohmeda, Inc. | 2004-09-02 |