GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact
FDA device recall Z-1808-2014 · posted 2014-06-17 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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".
- Action taken
- 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
- Status
- Terminated
- Product code
- CCL
- Quantity affected
- 4,961 (1,946 units US, 3,015 units OUS)
- Distribution
- 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
- Date initiated
- 2014-05-23
- Date posted
- 2014-06-17
- Date terminated
- 2015-10-21
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC (K051092) | GE Healthcare | 2005-05-25 |