100-120V 2001 Pulse Oximeter With Mars - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
This recall has been terminated (originally issued April 8, 2010).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- November 19, 2009
- Posted
- April 8, 2010
- Terminated
- December 8, 2016
- Recall Number
- Z-1302-2010
- Quantity
- 1,368
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MAURITIUS, MEXICO, NETHERLANDS, NETHERLANDS ANTILLES, NEW ZEALAND, NICARAGUA, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SAINT LUCIA, SAIPAN, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and VIRGIN ISLANDS.
Lot / Code Info
Model/ID 9400-00
Root Cause
Nonconforming Material/Component
Action Taken
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 letters were sent to Distributors describing the problem and giving them instructions for notifying customers and actions to be taken. Customers are to visually inspect the affected cords, complete the Customer Reply Power Cord Order Form, and follow the instructions to dispose of affected cords. Further information or support concerning this issue can be obtained by contacting a Philips representative at 1-800-722-9377.