Z-0331-2022Class II

Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as...

Name: Z-0331-2022 Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2021-10-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-10-15 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral... on 2021-10-15. FDA classified it as Class II and gives the reason as "Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0331-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-15
Posted: 2021-12-02
Terminated: 2024-05-13
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)
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: All software versions prior to 3.10.2. GTIN: 00630414949581 and 00630414989556 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0331-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0330-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-08	2021-12-02
Z-0331-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-08	2021-12-02

Product code JJE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)