Terminated

GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

FDA Recall Z-1808-2014 · Posted 2014-06-17

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeCCL

Date Initiated2014-05-23

Date Terminated2015-10-21

Product Quantity4,961 (1,946 units US, 3,015 units OUS)

Reason for Recall

Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. If this issue occurs, the monitor will show an alarm note on monitor screen of either "Low gas sample flow" or "Check sample gas out".

Firm Action

GE Healthcare sent an "Urgent Medical Device Correction" letter dated May 23, 1014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions they should contact Technical support at 1-800-558-7044 or your local Service Representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US (nationwide): All states in continental USA including DC except DE, ME, ND, RI & VT. and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GHANA, HONG KONG, HUNGARY, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAHKSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT LEBANON, LITHUANIA, MACEDONIA, MAURITIUS,MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY,, PANAMA, PERU, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and URUGUAY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051092DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACCGE Healthcare · 2005-05-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.