FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2344-2008
- Recalling firm
- Respironics, Inc.
- Product
- 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
- Status
- Terminated
- Initiated
- 2008-07-08
- Posted
- 2008-09-18
- Terminated
- 2009-04-23
- 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.
- Lot, serial or model codes
- Model/Catalog number PLV-100. Circuit board part numbers 1034786 version 5 or 1036038 version 3
- 510(k) numbers
- ["K832467"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2518422
- Firm city
- Murrysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28