Recall Z-1294-2010 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Philips Healthcare Inc.
Tidal Wave - 615, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care.
| Date | Apr 8, 2010 (initiated Nov 19, 2009) |
| Status | Terminated |
| Reason | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock. |
| Root cause | Nonconforming Material/Component |
| Action | Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside plug. The issue affects medical device power cords equipped with a plug that has a prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug ("taller bridge" design). Medical device power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected. Urgent Medical Device Correction let |
| Quantity | 19 |
| Distribution | Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, Aruba, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, Denmark, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONES |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963327 | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 Novametrix Medical Systems, Inc., Nov 20, 1996 |