PLV-100 Portable Lifecare Ventilator Life support ventilation The device is intended to mechanically control or assist p
FDA device recall Z-2344-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure.
- Action taken
- 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.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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.
- Date initiated
- 2008-07-08
- Date posted
- 2008-09-18
- Date terminated
- 2009-04-23
- Location
- Murrysville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORTABLE LIFECARE VENTILATOR PLV-100 (K832467) | Lifecare Services, Inc. | 1983-10-20 |