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U.S. Department of Health and Human Services

Class 2 Device Recall Power circuit board assembly kits

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  Class 2 Device Recall Power circuit board assembly kits see related information
Date Initiated by Firm February 22, 2008
Date Posted August 13, 2008
Recall Status1 Terminated 3 on August 16, 2012
Recall Number Z-1469-2008
Recall Event ID 46850
510(K)Number K981371  K984056  K002881  K010508  K040540  
Product Classification Assembly kit - Product Code CBK
Product Replacement Kit, Power PCBA with Memory PCBA. REF 14425.
Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
Code Information Lot number: PWRMK0325902, PWRMK0407201, PWRMK0420105, PWRMK0436501, PWRMK0501101, PWRMK0504603, PWRMK0505402, PWRMK0506602, PWRMK0510303, PWRMK0510804, PWRMK0512201, PWRMK0512303, PWRMK0514313, PWRMK0515201, PWRMK0515701, PWRMK0517802, PWRMK0518701, PWRMK0526503
Recalling Firm/
Cardinal Health 203, Inc
17400 Medina Rd Ste 100
Minneapolis MN 55447-1341
Manufacturer 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.
FDA Determined
Cause 2
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 2,503 ( 1,128 US, 1,375 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = PASCO LABORATORIES, INC.
510(K)s with Product Code = CBK and Original Applicant = PULMONETIC SYSTEMS, INC.