Recall Z-0354-06 ยท CBK Ventilator, Continuous, Facility Use
Respironics California Inc
The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keyp
| Date | Jan 6, 2006 (initiated Nov 18, 2005) |
| Status | Terminated |
| Reason | During product testing of the PLV Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient. |
| Root cause | Other |
| Action | On November 18, 2005 all affected customers received a personal phone call from Respironics explaining the recall situation in detail. On November 21, 2005, an advisory notice was sent to customers via fax, email, or mail, instructing customers to only use your PLV Continuum Ventilator in the 'Face Foward' orientation. The firm will contact customers with further information shortly to assure that this situation is positively resolved. Customers were instructed to Only use the PL V Continuum Ventilator in the 'Face Forward' orientation. In the event that a customer requires the applicat |
| Quantity | 268 |
| Distribution | Nationwide, Taiwan, Saudi Arabia, Netherlands, Hong Kong, Canada, Brazil, Australia, and Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022750 | PLV CONTINUUM VENTILATOR, MODEL P1000 Respironics California, Inc., Nov 20, 2003 |