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U.S. Department of Health and Human Services

Class 2 Device Recall Solar

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  Class 2 Device Recall Solar see related information
Date Initiated by Firm June 14, 2002
Date Posted November 06, 2003
Recall Status1 Terminated 3 on November 08, 2005
Recall Number Z-0092-04
Recall Event ID 27558
Product Classification Detector And Alarm, Arrhythmia - Product Code DSI
Product Solar 8000M Patient Monitor with software versions 3A, 3B and 3C
Code Information All devices with Solar 8000M software versions 3A, 3B or 3C are affected 
Recalling Firm/
General Electric Medical Systems Information Technology
8200 W Tower Ave
Milwaukee WI 53223-3219
For Additional Information Contact Paul Hanneman
Manufacturer Reason
for Recall
Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display, and selected gain settings for a selected waveform.
FDA Determined
Cause 2
Action A 'Patient Safety Alert' letter dated June 14, 2002 was sent to the consignees. The letter recommended certain actions to avoid the problems and stated that the firm''s field service team would contact the consignees to schedule a software revision to eliminate the problem.
Quantity in Commerce 2809 monitors and 238 software update kits
Distribution The devices were distributed nationwide in the United States and worldwide.
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.