Class 2 Device Recall Transcutaneous C02 & O2 Monitor

• Date Initiated by Firm: November 19, 2009
• Date Posted: April 08, 2010
• Recall Status: Terminated on December 08, 2016
• Recall Number: Z-1270-2010
• Recall Event ID: 53869
• 510(K)Number: K890517
• Product Classification: Cutaneous Carbon Dioxide Monitor - Product Code LKD
• Product: Transcutaneous C02 & O2 Monitor - 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.
• Code Information: Model/ID # 6590-00
• Recalling Firm/ Manufacturer: Philips Healthcare Inc.; 3000 Minuteman Road; Andover MA 01810
• For Additional Information Contact: 978-687-1501
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 316
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LKD and Original Applicant = NOVAMETRIX MEDICAL SYSTEMS, INC.