Class 2 Device Recall Dimension Vista Intelligent Lab System

• Date Initiated by Firm: May 21, 2015
• Date Posted: July 09, 2015
• Recall Status: Terminated on March 10, 2017
• Recall Number: Z-2054-2015
• Recall Event ID: 71315
• 510(K)Number: K051087
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
• Code Information: Siemens Material Number (SMN): 10284473, 10488224, 10444801, 10444802
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 Gbc Dr Ms 514; PO BOX 6101; Newark DE 19702-2466
• For Additional Information Contact: Customer Support; 800-441-9250
• Manufacturer Reason for Recall: Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong reagent or no reagent delivery. This may lead to unflagged, unexpected low results and results flagged with assay errors.
• FDA Determined Cause: Software design (manufacturing process)
• Action: Siemens sent an Urgent Medical Device Correction letter dated May 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer: For the corresponding issues listed above, please perform the following: Issue 1: If you experience this situation, sample processing can be resumed using the step(s) below: Step 1: From the Operation Icon select PAUSE, then immediately return to the Operation Icon and select Cancel PAUSE. Sample aliquotting should immediately resume. Step 2: If sample processing does not resume after Step 1, wait until the instrument displays System Ready, then restart the system software per the Vista Operator Guide, Section 2, Controlled Shutdown-Restart procedure. Issue 2: To prevent the Reagent Servers from temporarily losing synchronization, Siemens recommends setting the Auto Dispose option to No for methods assigned to Reagent Server 2 (see instructions below). These empty or expired reagent cartridges will now remain on the instrument and require the operator to unload them. Please consult your Vista Operators Guide or method Instructions for Use when results with flags and/or errors occur. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center-Technical Solutions at (800) 441-9250 or your local Siemens technical support representative.
• Quantity in Commerce: 2315
• Distribution: Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Austria, Australia, Belgium, Canada, Denmark, France, Finland, Germany, Japan, Italy, New Zealand, Netherlands, Czech Republic, Portugal, Republic Korea, Norway, Spain, Switzerland, Slovakia, Saudi Arabia, Slovenia, and United Kingdom,
• 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 = JJE