Siemens Healthcare Diagnostics, Inc.: Dimension Vista 500- 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: 10284473 (US) and 10488224 (OUS)

Recall number

Z-0331-2022

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

Dimension Vista 500- 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: 10284473 (US) and 10488224 (OUS)

Status

Terminated

Initiated

2021-10-15

Posted

not on file

Terminated

2024-05-13

Reason

Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays

Root cause

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

1326 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.

Lot, serial or model codes

All software versions prior to 3.10.2. GTIN: 00630414949581 and 00630414989556 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)

510(k) numbers

["K051087","K143720"]

PMA numbers

not on file

Product code

JJE

Firm FEI

2517506

Firm city

Newark

Firm state

DE

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy