Recall Z-1191-06 ยท CBK Ventilator, Continuous, Facility Use
Respironics, Inc.
NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
| Date | Jul 1, 2006 (initiated Sep 19, 2005) |
| Status | Terminated |
| Reason | Gas input pressures over 62 psi may cause CPAP pressure oscillation |
| Root cause | Other |
| Action | The recalling firm issued a recall letter to their customers dated 9/19/05 informing them of the problem and the corrective action. (fitting unit with external 50 psi pressure regulator for both air and oxygen) |
| Quantity | 232 units |
| Distribution | World wide (including medical facilities in AZ, CA, CO, GA, IA, IL, MA, MD, MN, MO, NC, NE, NH, NJ, OH, OK, OR, PA, PR, TN, TX, VA, WI, and WV. Japan, Ireland, Great Britain, Sweden, Portugal, France, Chile, Argentina, Hong Kong, South Africa, Greece, Egypt, Saudia Arabia, Norway, Spain, Belgium an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040862 | GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM Caradyne, Ltd., Jun 30, 2004 |