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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista 500 and 1500 Systems

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  Class 2 Device Recall Dimension Vista 500 and 1500 Systems see related information
Date Initiated by Firm October 15, 2021
Create Date December 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-0330-2022
Recall Event ID 89008
510(K)Number K051087  K143720  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Dimension Vista 1500 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 fluid
SMN: 10444801(US) and 10444802 (OUS)
Code Information All software versions prior to 3.10.2. GTIN: 00630414949741 and 00630414945460 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr
Newark DE 19702-2466
For Additional Information Contact SAME
800-441-9250
Manufacturer Reason
for Recall		 Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
FDA Determined
Cause 2		 Software design
Action Siemens issued Urgent Medical Device Correction letter dated 10/27/21 to US Customers (VSW-22-01.A.US) and OUS Customers will be sent Urgent Field Safety Notice (VSW-22-01.A.OUS) to inform them of the issue and instruct them on setting the HIL index for the affected assays if applicable. The Dimension Vista software has been updated with the correct HIL index default settings recommended in this letter and included in software version 3.10.2. Letter states reason for recall, health risk and action to take: For the products listed in Table 1, please perform the following steps if the HIL feature is activated on your Dimension Vista System. If your laboratory is not using the HIL feature and it is not activated on your system no action is required: If the HIL indices for Dimension Vista FOL are activated, be sure to set the I index (icterus) to 6 which is aligned with the information in the Dimension Vista FOL IFU. If the HIL indices for Dimension Vista AMM are activated, be sure to set the L index (lipemia) to 2 which is aligned with the information in the Dimension Vista AMM IFU. Note: Instructions for setting HIL indices can be found in the Dimension System Operator s Guide, in Section Configuration, System Configuration. If the HIL indices for Dimension Vista CTNI are activated, be sure to set the I index (icterus) to 7 which is aligned with the information in the Dimension Vista CTNI IFU. If the HIL indices for Dimension Vista TPSA and/or FPSA are activated, be sure to set the H index (hemolysis) to 7 and the I index (icterus) to 6 which is aligned with the information in the Dimension Vista TPSA and FPSA IFUs. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days to Siemens Healthineers for reporting to the Authorities. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your lo
Quantity in Commerce 1407 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = DADE BEHRING, INC.
510(K)s with Product Code = JJE and Original Applicant = Siemens Healthcare Diagnostics
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