DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
FDA device recall Z-1814-2010 · posted 2010-06-22 · Terminated
Recall details
- Recalling firm
- Ge Healthcare, Llc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DPZ
- Quantity affected
- 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,
- Date initiated
- 2010-04-29
- Date posted
- 2010-06-22
- Date terminated
- 2013-12-03
- 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 |