Z-1274-2010

Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometric, carbon dioxide...

Name: Z-1274-2010 Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometric, carbon dioxide...
Creator: Philips Healthcare Inc.
Published: 2009-11-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-11-19 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring on 2009-11-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1274-2010
Status: Terminated
Initiated: 2009-11-19
Posted: 2010-04-08
Terminated: 2016-12-08
Recalling firm: Philips North America LLC
Product: Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring.
Product code: BZC Calculator, Pulmonary Function Data
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.
Root cause tag: manufacturing process
FDA 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 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: 215
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.
Product codes and lots: Model/ID # 6758-00

Product code BZC

K963380Class IICo 2 Smo PlusNovametrix Medical Systems, Inc. / cleared 1997-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)