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U.S. Department of Health and Human Services

Class 2 Device Recall CardiAssist

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 Class 2 Recall
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Date Posted July 07, 2009
Recall Status1 Open
Recall Number Z-1582-2009
Recall Event ID 52223
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.
Code Information CardioAssist Model 4000 Serial 4018
Recalling Firm/
Cardiomedics Incorporated
7 Whatney
Suite B
Irvine, California 92618-2839
Manufacturer Reason
for Recall
Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape of the waveform in certain circumstances where there was excessive motion artifact.
Action Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5.
Quantity in Commerce 1
Distribution Florida
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55