Recall Z-2344-2008 ยท CBK Ventilator, Continuous, Facility Use
Respironics, Inc.
PLV-100 Portable Lifecare Ventilator Life support ventilation The device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Life support ventilation
| Date | Sep 18, 2008 (initiated Jul 8, 2008) |
| Status | Terminated |
| Reason | Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure. |
| Root cause | Finished device change control |
| Action | The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/8/08. The letter informed the customer of the problem and the need to contact the firm for a replacement. Contact Respironics Customer Service at 1-877-387-331 for assistance. |
| Quantity | 197 |
| Distribution | Worldwide Distribution ---USA: NC, IL, NJ, MO, TX , OH, IA, and OK and countries of Japan, Denmark, Korea, Australia, Finland, Canada, Argentina, New Zealand, Hong Kong, and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K832467 | PORTABLE LIFECARE VENTILATOR PLV-100 Lifecare Services, Inc., Oct 20, 1983 |