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Class 2 Device Recall Seno Advantage 2.2 |
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Date Initiated by Firm |
May 24, 2012 |
Date Posted |
October 24, 2012 |
Recall Status1 |
Terminated 3 on December 11, 2012 |
Recall Number |
Z-0125-2013 |
Recall Event ID |
61612 |
510(K)Number |
K033400
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Product Classification |
System, image processing, radiological - Product Code LLZ
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Product |
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02
A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. |
Code Information |
000000010005GS 000000010004GS 000000010009GS 000000010007GS 000000010006GS 000000010010GS 000000010001GS 000000010002GS 000000010008GS 000000010003GS 00000L3A4391A7 00000L3A8D5CF0 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact |
262-513-4122
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Manufacturer Reason for Recall |
GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.
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FDA Determined Cause 2 |
Software design |
Action |
Consignees were sent on 5/24/12 a GE Healthcare "Urgent Medical Device Correction" letter dated May 23, 2012. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction. Customers should verify if their workstation is affected. GE Healthcare will correct all affected workstations by providing a software upgrade and Operator Manual update. A GE Healthcare service representative will contact you to arrange this correction. This activity will be performed at no cost to you.
If you have any questions or concerns regarding this notification, please call one of the following phone numbers:
United States: 800 437 1171
Japan: 0120 - 055 - 919
For other countries, please contact your local GE Healthcare Service Representative. |
Quantity in Commerce |
12 |
Distribution |
Worldwide Distribution -- USA (nationwide) including states of: CA, CT, NY, TX, and MS and countries of TAIWAN, ITALY, CANADA, and BAHRAIN |
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 = LLZ and Original Applicant = GE MEDICAL SYSTEMS W-400
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