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Terminated

The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings.

FDA Recall Z-1485-04 · Posted 2004-09-28

Recalling FirmCardinal Health 203, Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2004-09-08
Date Terminated2008-05-28
Product Quantity10,299 ventilators

Reason for Recall

Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation to the patient.

Firm Action

A letter titled "Important Safety Information", dated September 7, 2004, was issued to all affected customers alerting them to the possibility of ventilator failure and providing instructions for recognizing and responding to the situation.

Root Cause

Other

Distribution Pattern

Nationwide and worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032226LTV-1000 VENTILATORPulmonetic Systems, Inc. · 2003-10-16K010608MODIFICATION TO LAP TOP VENTILATOR (LTV)Pulmonetic Systems, Inc. · 2001-03-20K002881VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000Pulmonetic Systems, Inc. · 2000-10-11K984056LTV 1000Pulmonetic Systems, Inc. · 1999-04-12K981371LTV 1000 VENTILATORPulmonetic Systems, Inc. · 1998-10-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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