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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris PC Unit 8015

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 Class 1 Recall
Alaris PC Unit 8015
see related information
Date Posted April 15, 2013
Recall Status1 Open
Recall Number Z-1098-2013
Recall Event ID 64728
Premarket Notification
510(K) Number
K051641 
Product Classification Pump, Infusion - Product Code FRN
Product Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Code Information unit model 8015 with software version 9.12
Recalling Firm/
Manufacturer
Carefusion Corporation
3750 Torrey View Ct
San Diego, California 92130-2622
Manufacturer Reason
for Recall
The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.
FDA Determined
Cause 2
DESIGN: Software Design
Action CareFusion sent an Urgent Medical Device Recall Notification letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. Customers are required to confirm receipt of the notification by returning the Recall Response card to Carefusion by postage-paid, self-addressed mail, fax, or email. Carefusion representatives will contact customers by telephone to schedule field remediation. For questions contact CareFusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266 and/or Technical Support at 888-812-3229.
Quantity in Commerce 9,241 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia and China.
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = CARDINAL HEALTH, ALARIS PRODUCTS
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