Pulmonetic Systems – LTV Series Ventilator

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

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

REASON:

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

CODE:

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

MANUFACTURER:

Pulmonetic Systems, Inc., Colton, CA.

RECALLED BY:

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

DISTRIBUTION:

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.

QUANTITY:

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.

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