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U.S. Department of Health and Human Services

Class 2 Device Recall Spanish 100120V Cosmo Plus 8100

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 Class 2 Device Recall Spanish 100120V Cosmo Plus 8100see related information
Date Initiated by FirmNovember 19, 2009
Date PostedApril 08, 2010
Recall Status1 Terminated 3 on December 08, 2016
Recall NumberZ-1275-2010
Recall Event ID 53869
510(K)NumberK963380 
Product Classification Pulmonary Function Data Calculator - Product Code BZC
ProductSpanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring.
Code Information model/ID # 6758-SPA
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 2
Nonconforming Material/Component
ActionPhilips 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 Commerce8
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = BZC
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