Z-1467-2008

Replacement Kit, Power PCBA with DC power cord. REF 11590. Pulmonetic Systems, 17400 Medina Rd., Suite 100...

Name: Z-1467-2008 Replacement Kit, Power PCBA with DC power cord. REF 11590. Pulmonetic Systems, 17400 Medina Rd., Suite 100...
Creator: Cardinal Health 203, Inc
Published: 2008-02-22
License: https://open.fda.gov/license/

Pulmonetic Systems, Inc. / initiated 2008-02-22 / Terminated / root cause: design

FDA source

Cardinal Health 203, Inc began a recall of Replacement Kit, Power PCBA with DC power cord. REF 11590. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA on 2008-02-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1467-2008
Status: Terminated
Initiated: 2008-02-22
Posted: 2008-08-13
Terminated: 2012-08-16
Recalling firm: Pulmonetic Systems, Inc.
Product: Replacement Kit, Power PCBA with DC power cord. REF 11590. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: 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 tag: design
FDA 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 in commerce: 503 (269 US, 234 OUS)
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 Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.
Product codes and lots: Lot number: PWRRK0324502, PWRRK0327403, PWRRK0334402, PWRRK0336401, PWRRK0402801, PWRRK0405015, PWRRK0406201, PWRRK0408407, PWRRK0419801, PWRRK0427307, PWRRK0429501, PWRRK0430301, PWRRK0434102, PWRRK0435701, PWRRK0501302, PWRRK0505404, PWRRK0515203, PWRRK0516001, PWRRK0526901, PWRRK0527803.

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)