Class 2 Device Recall Ventana Image Analysis System (VIAS)

• Date Initiated by Firm: June 26, 2007
• Date Posted: March 18, 2008
• Recall Status: Terminated on March 26, 2012
• Recall Number: Z-0571-2008
• Recall Event ID: 45798
• 510(K)Number: K061613
• Product Classification: Pathology Image Analysis System - Product Code NQN
• Product: Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Systems, Inc., Tucson, AZ 85755
• Code Information: Serial Numbers: HIS06086 HIS05042 HIS06047 HIS05018 HIS05022 HIS06046 HIS06092 HIS06059 HIS06053 HIS05053 HIS06035 HIS06038 HIS05026 HIS06100 HIS06021 HIS06074 HIS05041 HIS05017 HIS06031 HIS05051 HIS06061 HIS06028 HIS05011 HIS06083 HIS06064 HIS06057 HIS06055 HIS05047 HIS05012 HIS06054 HIS06073 HIS06088 HIS06076 HIS06002 HIS06001 HIS06004 HIS06034 HIS06015 HIS06098 HIS06069 HIS05044 HIS06033 HIS06050 HIS05046 HIS06030 HIS06095 HIS06067 HIS05028 HIS06027 HIS06056 HIS05033 HIS06049 HIS06026 HIS06008 HIS05049 HIS05013 HIS06079 HIS06072 HIS06089 HIS06084 HIS06044 HIS06007 HIS05027 HIS06051 HIS06052 HIS05025 HIS06096 HIS06066 HIS06039 HIS06065 HIS06019 HIS05052 HIS06029 HIS06022 HIS06068 HIS05048, and HIS05058
• FEI Number: 1000125183
• Recalling Firm/ Manufacturer: Ventana Medical Systems Inc; 1910 E Innovation Park Dr; Tucson AZ 85755-1962
• For Additional Information Contact: Jeff Boone; 520-877-7237
• Manufacturer Reason for Recall: Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software upgrade adds the algorithm (Slidetype) for the PATHWAY anti-HER-2/neu (4B5) antibody to the VIAS system.
• FDA Determined Cause: Software change control
• Action: Beginning in 6/07, Ventana Medical Systems, Inc., made phonecalls to labs asking to confirm software version, date of upgrade if available and confirmation of whether site uses 4B5 and Imaging together. A phone script was provided. Customers with systems not ugraded were to upgrade before further use of system. A notification letter dated 8/17/2007 was later sent to VIAS customers advising that the software upgrade from February 1 , 2007 may not have been completed on their system. This software upgrade adds the algorithm (Slidetype) for the PATWAY anti-HER-2/neu (4B5) antibody to their VIAS system . This Slidetype is cleared for marketing and is required prior to imaging slides stained with PATHWAY anti-HER-2/neu (4B5). The letter also advises that their VIAS and NEXES systems are conneded to the internet which enables this upgrade to be performed remotely with the support of the Ventana Medical Systems Customer Support Center (CSC). customers are instructed to call the CSC to carry out the upgrade or to schedule a Technical Applications Specialist (TAS) to assist with the upgrade in their lab. Arrangements for the upgrade are to be made prior to imaging slides stained with PATHWAY anti-HER-2/neu (4B5).
• Quantity in Commerce: 77 devices
• Distribution: Nationwide and Canada
• 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 = NQN