| Class 2 Device Recall QVue Continuous Cardiac Output (CCO)/SO2 computer | |
Date Initiated by Firm | August 11, 2009 |
Date Posted | November 09, 2009 |
Recall Status1 |
Terminated 3 on April 04, 2012 |
Recall Number | Z-0147-2010 |
Recall Event ID |
53257 |
510(K)Number | K932414 |
Product Classification |
Computer, Diagnostic, Pre-Programmed, Single-Function - Product Code dxg
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Product | Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04-31, 52230-04-33, 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/ Manufacturer |
Hospira Inc
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = dxg
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