Reported Jun 25, 2014 · 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…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
- Mfg Lot or Serial #
3,620 of 3,620 codes
670412067041266704128670412967041326704133670413467041386704143670414667041476704150670415167041526705240670524167052426705245670524667052486705249670525467052566705258670525967052616705262670526367052646705266670527167052746705276670527767052786705279670528067052826705283670528467052876705313670531667053276705328670532967053336705334670533667053376705338670533967053406705341670534867053526705360670647567064776706478
- Mfg Lot or Serial #
- Amount recalled
- 4,961 (1,946 units US, 3,015 units OUS)
Where it was sold
Why it was recalled
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".
This product could cause temporary or reversible health problems — stop using it.
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