Dimension Vista Integrated System

• 2 recalls, same reason

  • Terminated Z-0331-2022 FDA Class II ·initiated 15 Oct 2021
  • Terminated Z-0330-2022 FDA Class II ·initiated 15 Oct 2021

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

• • Terminated Z-1014-2019 FDA Class II ·initiated 12 Dec 2018

  When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination.

• • Terminated Z-0616-2019 FDA Class II ·initiated 16 Oct 2018

  Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample, the Dimension Vista instrument may continue to deliver the cancelled sample or vial contents to the aliquot well(s). Future samples may be assigned to the same aliquot well(s) and become contaminated with the existing contents or overflow of the aliquot well may occur potentially contaminating a surrounding well(s). This issue only occurs when an operator manually cancels a test(s) for calibration, quality control (QC) or patient sample while the instrument is in the process of aliquotting the sample.

• • Terminated Z-1703-2017 FDA Class II ·initiated 3 Mar 2017

  Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result.

• 2 recalls, same reason

  • Terminated Z-1886-2016 FDA Class II ·initiated 24 Mar 2016
  • Terminated Z-1885-2016 FDA Class II ·initiated 24 Mar 2016

  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.

• • Terminated Z-1622-2016 FDA Class II ·initiated 16 Feb 2016 ·via K051087, on the same 510(k)

  Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.

• • Terminated Z-2054-2015 FDA Class II ·initiated 21 May 2015

  Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong reagent or no reagent delivery. This may lead to unflagged, unexpected low results and results flagged with assay errors.

• • Terminated Z-0838-2015 FDA Class II ·initiated 5 Nov 2014

  Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.

• • Terminated Z-0024-2015 FDA Class II ·initiated 28 Aug 2014 ·via K051087, on the same 510(k)

  Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been d

• • Terminated Z-1733-2014 FDA Class II ·initiated 14 Apr 2014

  A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.

• • Terminated Z-0851-2014 FDA Class II ·initiated 7 Oct 2013

  When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.

• • Terminated Z-2088-2013 FDA Class II ·initiated 19 Jun 2013

  Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot

• • Terminated Z-0430-2014 FDA Class II ·initiated 20 May 2013

  There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1

• • Terminated Z-1454-2012 FDA Not yet classified ·initiated 16 Jan 2012

  Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use for the respective method. This issue is isolated to Vista(R) software version 3.4. Customers who have not made any changes to the default method configurations

• 3 recalls, same reason

  • Terminated Z-0646-2012 FDA Unclassified (pre-2012) ·initiated 31 Oct 2011
  • Terminated Z-0644-2012 FDA Unclassified (pre-2012) ·initiated 31 Oct 2011
  • Terminated Z-0645-2012 FDA Unclassified (pre-2012) ·initiated 31 Oct 2011

  Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IMT sensor. The results can be elevated approximately 10-20% which may cause QC recovery being out of acceptable ranges. Patient Urine sodium results may also b

• • Terminated Z-0031-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011

  Siemens Healthcare Diagnostics has confirmed a low frequency defect in the molding of the Cuvettes that may result in Cuvette Ring and Cuvette Loader jams. It has been determined that the issue is related to a molding defect with the Cuvette flange or "wing" breaking, resulting in an error condition. Therefore, patient results are not impacted.

• • Terminated Z-0139-2011 FDA Unclassified (pre-2012) ·initiated 19 Aug 2010 ·via K051087, on the same 510(k)

  High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.

• • Terminated Z-0121-2011 FDA Unclassified (pre-2012) ·initiated 23 Jul 2010

  the EasyLink QCFIRST custom rule does not operate as intended.

• • Terminated Z-2423-2010 FDA Unclassified (pre-2012) ·initiated 5 May 2010

  Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur.

• • Terminated Z-2117-2010 FDA Unclassified (pre-2012) ·initiated 15 Mar 2010

  Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin.

• • Terminated Z-0980-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009

  Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable.

• 3 recalls, same reason

  • Terminated Z-1038-2010 FDA Unclassified (pre-2012) ·initiated 22 Oct 2009
  • Terminated Z-1037-2010 FDA Unclassified (pre-2012) ·initiated 22 Oct 2009
  • Terminated Z-1039-2010 FDA Unclassified (pre-2012) ·initiated 22 Oct 2009

  Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.

• • Terminated Z-1205-2010 FDA Unclassified (pre-2012) ·initiated 1 Sep 2009 ·via K051087, on the same 510(k)

  Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus volume to the low sensitivity aliquot (second aliquot). The surplus sample volume is occasionally insufficient to and can cause short sampling on the last test.

• • Terminated Z-1991-2009 FDA Unclassified (pre-2012) ·initiated 14 Jul 2009

  incorrect results may be transmitted to LIS

• • Terminated Z-1017-2010 FDA Unclassified (pre-2012) ·initiated 16 Jun 2009

  Incorrect result: patient sample BUN results reported may be higher or lower than actual level.

• • Terminated Z-1174-2007 FDA Unclassified (pre-2012) ·initiated 3 Jul 2007

  Sample ID and Patient results could be associated with the wrong patient

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K051087 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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