Recall Z-1470-2008 ยท CBK Ventilator, Continuous, Facility Use
Cardinal Health 203, Inc
Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
| Date | Aug 13, 2008 (initiated Feb 22, 2008) |
| Status | Terminated |
| Reason | The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Recall letter dated February 22, 2008 was sent to ventilator consignees/owners and distributors. The letter describes the issue, identifies the affected devices, states that the devices will be corrected by Cardinal Health and provides direction to verify ventilator operation and audible alarm function daily. Service Centers were provided information to identify affected printed circuit board assembly replacement kits' lot numbers and asked to return them. An "Update" was mailed 03/04/2008 to identify additional ventilator serial numbers that also need correction. |
| Quantity | 175 (OUS only) |
| Distribution | Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New |
| 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 |
| K010508 | PASCO MIC AND MIC/ID PANELS Pasco Laboratories, Inc., Apr 23, 2001 |
| K040540 | MODIFICATION TO LTV 1000 VENTILATOR Pulmonetic Systems, Inc., Apr 29, 2004 |
| K981371 | LTV 1000 VENTILATOR Pulmonetic Systems, Inc., Oct 30, 1998 |
| K984056 | LTV 1000 Pulmonetic Systems, Inc., Apr 12, 1999 |