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Dimension Vista 1500 In-vitro diagnostic device intended to… recallZ-0330-2022 · Siemens Healthcare Diagnostics, Inc. · initiated Oct 15, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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

Recall details

Recall number
Z-0330-2022
Status
Terminated
Initiated by the company
Oct 15, 2021
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1407 units
Product code
JJE
FDA submissions
K143720, K051087
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 description

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 (models, lots, serial numbers)

All software versions prior to 3.10.2. GTIN: 00630414949741 and 00630414945460 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)

Other devices under the same FDA submission

5 devices cleared under K143720, K051087 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 89008).

Sources and updates

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