Recall Z-1680-2015 ยท CCL Analyzer, Gas, Oxygen, Gaseous-Phase
GE Healthcare
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5
| Date | May 28, 2015 (initiated Apr 24, 2015) |
| Status | Terminated |
| Reason | A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. This water trap occlusion could cause a loss of respiratory airway gas monitoring. |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#36111 dated April 24, 2015. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, & Director of Biomedical Engineering, The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. A confirmation form is asked to be returned and GE will replace all affected product. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 5,018 (US = 2,948 / OUS = 2,070) |
| Distribution | Worldwide Distribution - US Nationwide including Washington DC, Puerto Rico. and the countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic , Egypt, Estonia, Fi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051092 | DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC GE Healthcare, May 25, 2005 |