Pulmonetic Systems – LTV Series Ventilator

Date of Recall 4/4/00
Date of Enforcement Report: 01/24/01

LTV Series Ventilator. Recall Nos. Z-154/156-1.


Failure of the LTV series ventilator software to detect a disconnect.


Model No. LTV 1000; Model No. LTV 950; Model No. LTV 900.


Pulmonetic Systems, Inc., Colton, CA.


Manufacturer, by letter on April 4, 2000. Firm-initiated recall ongoing.


Nationwide, Puerto Rico, Australia, Brazil, Canada, Colombia, Chile,
China, England, Greece, Hong Kong, India, Israel, Japan, Malaysia,
Mexico, New Zealand, Poland, Sweden, Taiwan ROC, Thailand.


2415 Units.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.