Dimension Vista® 500 Intelligent Lab System 10488217Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00630414593517), received between Mar 5, 2018 and Sep 17, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 reports).

35 other recalls cover devices cleared under the same FDA submission (K051087, K143720); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT CUVETTE WASHER A PROBE TRAVEL WAS NOT LOCKED ON THE DIMENSION VISTA 500 INSTRUMENT. WHILE TROUBLESHOOTING THIS MATTER, THE CUSTOMER OBSERVED A GREEN CONTAMINATE IN THE TUBING. IN ATTEMPT TO BLEACH THE TUBING, AN OPERATOR WAS SPLASHED WITH BLEACH. THE OPERATOR WIPED HER FACE, RINSED HER EYES AND VISITED EMERGENCY ROOM, WHERE THEY FOLLOWED THE NEEDLE EXPOSURE PROTOCOL. THE OPERATOR WAS TESTED FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV), WHICH RECOVERED NEGATIVE. NO TREATMENT WAS REQUIRED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241477 ↗
• MalfunctionSep 16, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE ORIGINAL DIMENSION VISTA 500 INSTRUMENT. THE REPEAT RESULT RECOVERED HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CO2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231679 ↗
• MalfunctionJun 30, 2023Low Test Results; Low Test Results

  TWO (2) DISCORDANT FALSELY DEPRESSED VANCOMYCIN (VANC) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM. THE FALSELY DEPRESSED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM AND THE ORIGINAL SYSTEM. HIGHER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. ONE OF THE RESULTS OBTAINED ON THE ALTERNATE DIMENSION VISTA® 500 SYSTEM WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED VANCOMYCIN (VANC) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244009 ↗
• MalfunctionJan 27, 2023Low Test Results; Low Test Results

  FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION VISTA 500 INSTRUMENT. THE SAMPLE IDENTIFIED AS (B)(6) WAS ALSO REPROCESSED ON THE ORIGINAL INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE INITIAL RESULTS. THE REPEAT RESULTS FROM THE ALTERNATE INSTRUMENT WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CO2 PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254945 ↗
• MalfunctionSep 27, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA 500 INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE DISCORDANT RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CO2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492914 ↗
• MalfunctionAug 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  TWO DISCORDANT, FALSELY DEPRESSED CARBON DIOXIDE PATIENT SAMPLES (2 PATIENTS) WERE OBTAINED ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLES WERE REPROCESSED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CARBON DIOXIDE PATIENT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163303 ↗
• MalfunctionDec 14, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT SHE RECEIVED A BRUISE AND SMALL CUT ON HER FACE WHEN SHE LEANED INTO THE DIMENSION VISTA 500 INSTRUMENT WHILE RUNNING A DIAGNOSTIC TEST TO ALIGN THE ALIQUOT PROBE. THE CUSTOMER HAD A PHYSICAL EXAMINATION IN THE EMERGENCY ROOM ON (B)(6) 2021 AND SHE INFORMED SIEMENS THAT THE CUT SHE OBTAINED WAS A SUPERFICIAL ABRASION THAT DID NOT REQUIRE MEDICAL TREATMENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INJURY THE CUSTOMER SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002500 ↗
• MalfunctionOct 28, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA 500 INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE DISCORDANT RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CO2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715374 ↗
• MalfunctionApr 16, 2019Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED TOTAL BILIRUBIN (TBIL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME INSTRUMENT AND A HIGHER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED TBIL RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517973 ↗
• MalfunctionNov 8, 2018Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. ON THE NEXT DAY, THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. ON (B)(6) 2018, THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS RUN ON AN ALTERNATE INSTRUMENT, RESULTING ACCEPTABLY. THE REPEAT RESULT OF 97 MIU/ML WAS REPORTED, AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW BHCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8052880 ↗
• MalfunctionJul 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE OPERATOR OF A DIMENSION VISTA 500 INSTRUMENT REPORTED INCORRECT CARDIAC TROPONIN I (CTNI) RESULTS ON ONE PATIENT. DIFFERENT SAMPLE DRAWS WERE OBTAINED FROM THE PATIENT AND TESTED ON THE SAME INSTRUMENT. THE RESULTS OBTAINED FOR FIRST, SECOND AND FIFTH SAMPLE DRAWS WERE ELEVATED. THE RESULTS FOR THIRD AND FOURTH SAMPLE DRAWS OBTAINED ON THE DIMENSION VISTA INSTRUMENT WERE ABOVE ANALYTICAL MEASUREMENT RANGE (>40 NG/ML). THESE RESULTS WERE TRANSMITTED TO A CENTALINK DATA MANAGEMENT SYSTEM AS NO RESULT. THE OPERATOR INADVERTENTLY REPORTED NO RESULT FROM CENTRALINK AS <0.02 NG/ML TO THE PHYSICIAN(S). THE CUSTOMER REPEATED THE SAMPLES IN QUESTION ON THE SAME INSTRUMENT, RESULTING HIGHER. THE CORRECT RESULTS FOR THE SAMPLES IN QUESTION WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE INCORRECT CTNI RESULTS BEING REPORTED TO THE PHYSICIAN(S).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689623 ↗
• MalfunctionJun 26, 2018Mechanical Problem; Mechanical Problem

  A DISCORDANT, FALSELY LOW CARBON DIOXIDE (CO2) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWICE ON AN ALTERNATE DIMENSION VISTA INSTRUMENT, RESULTING HIGHER BOTH TIMES. THE RESULTS OBTAINED ON THE ALTERNATE DIMENSION VISTA INSTRUMENT WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW CO2 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7637173 ↗
• MalfunctionMar 5, 2018Mechanical Problem; Mechanical Problem

  A DISCORDANT, FALSELY LOW BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME DIMENSION VISTA INSTRUMENT AND ON AN ALTERNATE DIMENSION VISTA INSTRUMENT, RESULTING HIGHER. THE CORRECTED RESULT FROM THE ALTERNATE INSTRUMENT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW BHCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7312710 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051087, K143720. One submission often covers many models, so check the product and lot details in each record.

• Z-0331-2022 · Oct 15, 2021 · Terminated
  Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determi
• Z-0330-2022 · Oct 15, 2021 · Terminated
  Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determi
• Z-1014-2019 · Dec 12, 2018 · Terminated
  Dimension Vista 500, Analyzer, chemistry Model no. 10284473
• Z-1015-2019 · Dec 12, 2018 · Terminated
  Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
• Z-0616-2019 · Oct 16, 2018 · Terminated
  Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral
• Z-0617-2019 · Oct 16, 2018 · Terminated
  Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral
• Z-1672-2018 · Jan 2, 2018 · Terminated
  Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge
• Z-1703-2017 · Mar 3, 2017 · Terminated
  Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemen
• Z-1886-2016 · Mar 24, 2016 · Terminated
  Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension
• Z-1885-2016 · Mar 24, 2016 · Terminated
  Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension V
• Z-1622-2016 · Feb 16, 2016 · Terminated
  Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of
• Z-2054-2015 · May 21, 2015 · Terminated
  Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
• Z-0838-2015 · Nov 5, 2014 · Terminated
  Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such a
• Z-0024-2015 · Aug 28, 2014 · Terminated
  Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista Syst
• Z-1733-2014 · Apr 14, 2014 · Terminated
  Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension V

…and 20 more.