Recall Z-2068-2014 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
GE Healthcare, LLC
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
| Date | Jul 18, 2014 (initiated Jun 11, 2014) |
| Status | Terminated |
| Reason | Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low CO2 values. |
| Root cause | Device Design |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated June 11, 2014, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction and Contact Information. For questions customers were instructed to contact Technical Support at 1-800-558-7044 or their local Service Representative. |
| Quantity | 2,948 (761 units US, 2,187 units OUS) |
| Distribution | Worldwide Distribution - USA nationwide, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BRAZIL, CANADA, CHILE, CHINA, Croatia, CZECH REPUBLIC, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, MALAYSIA, NET |
| FDA record | Open on fda.gov |