Z-2344-2008

PLV-100 Portable Lifecare Ventilator Life support ventilation The device is intended to mechanically control...

Name: Z-2344-2008 PLV-100 Portable Lifecare Ventilator Life support ventilation The device is intended to mechanically control...
Creator: Respironics, Inc.
Published: 2008-07-08
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2008-07-08 / Terminated

FDA source

Respironics, Inc. began a recall of PLV-100 Portable Lifecare Ventilator Life support ventilation The device is intended to mechanically control or assist patient breathing by delivering a... on 2008-07-08. The reason FDA records is "Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2344-2008
Status: Terminated
Initiated: 2008-07-08
Posted: 2008-09-18
Terminated: 2009-04-23
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
Product code: CBK Ventilator, Continuous, Facility Use
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.
FDA 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 in commerce: 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.
Product codes and lots: Model/Catalog number PLV-100. Circuit board part numbers 1034786 version 5 or 1036038 version 3

Product code CBK

K832467Class IIPortable Lifecare Ventilator Plv-100Lifecare Services, Inc. / cleared 1983-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)