Recall Z-1272-2010 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
Philips Healthcare Inc.
Spanish 100-120V TCOM-860, Respironics/Philips product. Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements.
| 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 | 10 |
| 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
| K890517 | TRANSCUTANEOUS O2/CO2 MONITOR Novametrix Medical Systems, Inc., Apr 14, 1989 |