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
This recall has been terminated (originally issued September 18, 2008).
- Company
- Respironics, Inc.
- Recall Initiated
- July 8, 2008
- Posted
- September 18, 2008
- Terminated
- April 23, 2009
- Recall Number
- Z-2344-2008
- Quantity
- 197
- Firm Location
- Murrysville, PA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Model/Catalog number PLV-100. Circuit board part numbers 1034786 version 5 or 1036038 version 3
Root Cause
Finished device change control
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.