DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A S
FDA device recall Z-2068-2014 · posted 2014-07-18 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 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, G
- Date initiated
- 2014-06-11
- Date posted
- 2014-07-18
- Date terminated
- 2016-03-29
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES (K052582) | GE Healthcare | 2005-10-14 |
| DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE (K043276) | Datex-Ohmeda | 2004-12-23 |