Recall Z-1485-04 ยท CBK Ventilator, Continuous, Facility Use
Cardinal Health 203, Inc
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.
| Date | Sep 28, 2004 (initiated Sep 8, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 10,299 ventilators |
| Distribution | Nationwide and worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002881 | VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 Pulmonetic Systems, Inc., Oct 11, 2000 |
| K010608 | MODIFICATION TO LAP TOP VENTILATOR (LTV) Pulmonetic Systems, Inc., Mar 20, 2001 |
| K032226 | LTV-1000 VENTILATOR Pulmonetic Systems, Inc., Oct 16, 2003 |
| K981371 | LTV 1000 VENTILATOR Pulmonetic Systems, Inc., Oct 30, 1998 |
| K984056 | LTV 1000 Pulmonetic Systems, Inc., Apr 12, 1999 |