FDAFDA · Food and drugs·Recall number Z-1808-2014
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.
Published June 25, 2014 · Recall initiated: May 23, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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".
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- Mfg Lot or Serial # 6704120 6704126 6704128 6704129 6704132 6704133 6704134 6704138 6704143 6704146 6704147 6704150 6704151 6704152 6705240 6705241 6705242 6705245 6705246 6705248 6705249 6705254 6705256 6705258 6705259 6705261 6705262 6705263 6705264 6705266 6705271 6705274 6705276 6705277 6705278 6705279 6705280 6705282 6705283 6705284 6705287 6705313 6705316 6705327 6705328 6705329 6705333 6705334 6705336 6705337 6705338 6705339 6705340 6705341 6705348 6705352 6705360 6706475 6706477 6706478 6706479 6706480 6706485 6706487 6706489 6706490 6707891 6707892 6707893 6707894 6707896 6707897 6707899 6707901 6707902 6707904 6707906 6707908 6707909 6707911 6707912 6707913 6707914 6707916 6707917 6707918 6707920 6707921 6707922 6707924 6707926 6707928 6707929 6707932 6707933 6707934 6707936 6707939 6707940 6707941 6707943 6707944 6707946 6707948 6707949 6707950 6707951 6707953 6707955 6707956 6707960 6707962 6707967 6707968 6707971 6707974 6707975 6707976 6707978 6707980 6707981 6707985 6707986 6708993 6708994 6708995 6708996 6709002 6709003 6709004 6709006 6709170 6709171 6709172 6709173 6709176 6709179 6709180 6709181 6709221 6709230 6709232 6709235 6710264 6710271 6710274 6710280 6710281 6710282 6710283 6710284 6710285 6710286 6710287 6710289 6710543 6710545 6710562 6710565 6710566 6710567 6710568 6710569 6710570 6710574 6710575 6710576 6710579 6710580 6710581 6710583 6710588 6710590 6710591 6710599 6710600 6710602 6710604 6710606 6711237 6711246 6711249 6711253 6711256 6711259 6711261 6711262 6711266 6711271 6711277 6711278 6711280 6711282 6711284 6711641 6711642 6711644 6711651 6711668 6711669 6711685 6711687 6713073 6713077 6713079 6713080 6713082 6713083 6713084 6713088 6713089 6713093 6713095 6713100 6713101 6713102 6713103 6713107 6713109 6713111 6713113 6713114 6713116 6713121 6713122 6713124 6713125 6713135 6713139 6713140 6713142 6713143 6713148 6713150 6713152 6713154 6713155 6713156 6713159 6713160 6713162 6713163 6713166 6713169 6713172 6713173 6713174 6713175 6713176 6713180 6713186 6713188 6713191 6715910 6715913 6715917 6715922 6715923 6715924 6715925 6715926 6716615 6716617 6716621 6716625 6716627 6716629 6716630 6716631 6716633 6716635 6716636 6716639 6716645 6716646 6716647 6716652 6716654 6716655 6716664 6716665 6716670 6716671 6716672 6716673 6716677 6716678 6716679 6716681 6716682 6716683 6716684 6716686 6716688 6716689 6716690 6716691 6716693 6716695 6716696 6716697 6716698 6716700 6716701 6716704 6716712 6716714 6716715 6716716 6716717 6716719 6716725 6716727 6716738 6716743 6716757 6719420 6719421 6719427 6719428 6719429 6719430 6719431 6719432 6719433 6719435 6719436 6719441 6719443 6719446 6719453 6719454 6719455 6719456 6719457 6719458 6719459 6719461 6719464 6719466 6719467 6719468 6719474 6719475 6719477 6719478 6719479 6719483 6719484 6719489 6719500 6719505 6719506 6719509 6719510 6719523 6719534 6719538 6719540 6719543 6719546 6719548 6719549 6721379 6721380 6721386 6721387 6721394 6721395 6721397 6721398 6721399 6721400 6721404 6721405 6721406 6721410 6721415 6721419 6721422 6721424 6721425 6721426 6721428 6721429 6721430 6721433 6721438 6721440 6721443 6721449 6721454 6721455 6721456 6721457 6721459 6721460 6721461 6721464 6721465 6721466 6721467 6721468 6721469 6721475 6721479 6722498 6722499 6722504 6722746 6722749 6722750 6722763 6722768 6722787 6722794 6722801 6722804 6722809 6722817 6723053 6723059 6723060 6723062 6723064 6723065 6723066 6723067 6723068 6723070 6723071 6723072 6723074 6723078 6723081 6723082 6723086 6723088 6723090 6723091 6723095 6723096 6
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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