Class 2 Device Recall Dimension Vista 500 Intelligent Lab System

• Date Initiated by Firm: March 24, 2016
• Date Posted: June 01, 2016
• Recall Status: Terminated on March 13, 2017
• Recall Number: Z-1885-2016
• Recall Event ID: 73885
• 510(K)Number: K051087
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected.; The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use
• Code Information: All serial numbers are affected.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics Inc.; 101 Silvermine Rd; Brookfield CT 06804-2047
• For Additional Information Contact: Helen Bouchard; 302-631-8248
• Manufacturer Reason for Recall: Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.
• FDA Determined Cause: Software design
• Action: Siemens sent an Urgent Medical Device Correction letter dated March 24, 2016, to all affected customers. Customers were advised to follow the instructions contained in the "Urgent Medical Device Correction" notification letter to help minimize or eliminate the impact that this specific software defect could cause until a software correction could be made (i.e instructions to minimize the impact of the software defect due to "Bad Sample Detect " False Transition" errors when processing front loaded samples) and (how to eliminate the impact of the software defect when processing front loaded samples). Customers were also asked to review the recall notification letter with their Medical Director and complete and return the Field Correction Effectiveness Check Form within 30 days. Customers with questions were advised to contact Siemens Customer Care Center - Technical Solutions at 800-441-9250 or their local Siemens technical support representative. For questions regarding this recall call 302-631-8248.
• Quantity in Commerce: 1301 units
• Distribution: Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.
• 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 and Original Applicant = DADE BEHRING, INC.