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U.S. Department of Health and Human Services

Class 2 Device Recall Oximetrix 3 SO2/CO Cardiac Output Computer

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  Class 2 Device Recall Oximetrix 3 SO2/CO Cardiac Output Computer see related information
Date Initiated by Firm August 11, 2009
Date Posted November 09, 2009
Recall Status1 Terminated 3 on April 04, 2012
Recall Number Z-0144-2010
Recall Event ID 53257
510(K)Number K853018  
Product Classification Computer, Diagnostic, Pre-Programmed, Single-Function - Product Code dxg
Product Power cord for Oximetrix 3 SO2/CO Cardiac Output Computer, list # 50130-04-07, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
Code Information AC power cords, all units of Part Numbers: 826-85559-001,  826-85559-003,  826-85559-008,  826-85559-010,  826-96057-003
Recalling Firm/
Hospira Inc
Manufacturer Reason
for Recall
Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.
FDA Determined
Cause 2
Component design/selection
Action Hospira initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and a letter to consignees was sent via UPS. The firm will replace affected cords and effectiveness checks will be conducted through tracking of servicing.
Quantity in Commerce 204,999 power cords distributed for all devices
Distribution Worldwide distribution.
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 = dxg and Original Applicant = OXIMETRIX, INC.