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U.S. Department of Health and Human Services

Class 2 Device Recall Millennium VG, Discovery VH, Varicam

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  Class 2 Device Recall Millennium VG, Discovery VH, Varicam see related information
Date Initiated by Firm September 03, 2004
Date Posted October 07, 2004
Recall Status1 Terminated 3 on July 24, 2006
Recall Number Z-0012-05
Recall Event ID 29988
510(K)Number K953801  
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Code Information Each unit has a unique serial code. All serial numbers are being recalled.
Recalling Firm/
Manufacturer		 General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Larry A. Kroger, Ph.D
262-544-3894
Manufacturer Reason
for Recall		 GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions in the volume curve in some MUGA studies, and result in calculated EF values lower (never higher) than actual values. A low EF value could lead to a physician decision to stop needed treatment.
FDA Determined
Cause 2		 Other
Action A letter dated August 5, 2004 was released to customers describing the issue and recommending that users pay special attention to any volume curve which appears to be abnormal or any EF values that appear to be lower than expected, and not to rely soley on this value for diagnosis purposes until they recieve the SW patch. A SW patch will be distributed shortly to all affected systems.
Quantity in Commerce 853 units
Distribution Nationwide throughout 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.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = ELSCINT, INC.
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