January 24, 2001
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,...
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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:

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