The Recall Desk

Manufacturer

Siemens Healthcare Diagnostics, Inc.

667 recalls in our database name Siemens Healthcare Diagnostics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
667
Critical
5
Severe
12
Most recent
2026-08-26

Of the 667 recalls from Siemens Healthcare Diagnostics, Inc. we have scored against our rubric, 5 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

251–275 of 667

  • HighFDA (Devices)·Z-0780-2019·2019-02-06

    Siemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues

    Siemens Healthcare Diagnostics is recalling 217 Atellica IM 1300 Analyzers worldwide due to multiple issues identified in software version 1.14.2 and lower.

    Product
    Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing systems.

    Product
    Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0783-2019·2019-02-06

    Siemens Recalls Atellica Sample Handler Prime Due to Software Issues

    Siemens Healthcare Diagnostics is recalling 410 Atellica Sample Handler Prime units because software version 1.14.2 and lower contain multiple issues.

    Product
    Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2019·2018-12-26

    Siemens Dimension Vista 1500 Recalled for Potential Sample Contamination

    Siemens is recalling Dimension Vista 1500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    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 intensities to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0616-2019·2018-12-26

    Siemens Dimension Vista 500 Recalled for Sample Contamination Risk

    Siemens is recalling Dimension Vista 500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    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 intensities to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0499-2019·2018-12-05

    Siemens Dimension Vista Lactate Dehydrogenase Reagent Cartridge Recall

    Siemens is recalling Dimension Vista Lactate Dehydrogenase reagent cartridges because they may produce falsely elevated results if used after Lactic Acid assays.

    Product
    Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0466-2019·2018-11-21

    Siemens Dimension Vista Lipase Reagent Cartridge Recalled for Variability

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Lipase Flex Reagent Cartridges due to lot-to-lot variability in quality control and patient results.

    Product
    Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2019·2018-11-21

    Siemens Lipase Reagent Cartridge Recall for Lot Variability

    Siemens Healthcare is recalling specific lots of Dimension Lipase Flex Reagent Cartridges due to lot-to-lot variability affecting quality control and patient results.

    Product
    Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2019·2018-11-14

    Siemens Dimension Thermal Chamber Motor Cable Recall for Insulation Defect

    Siemens is recalling 277 Dimension thermal chamber motor cables worldwide due to single insulation instead of required double insulation, posing a potential electrical shock risk.

    Product
    Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 006304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2019·2018-10-31

    Siemens APTIO Rack Input Module Recall for Missing Pacemaker Warning

    Siemens Healthcare Diagnostics is recalling 441 APTIO Rack Input Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO RACK INPUT MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0209-2019·2018-10-31

    Siemens APTIO Input/Output Modules Recalled for Missing Pacemaker Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO Input/Output Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO INPUT/OUTPUT MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0212-2019·2018-10-31

    Siemens APTIO 15000 Refrigerated Storage Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO 15000 Refrigerated Storage Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO 15000 REFRIGERATED STORAGE MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0216-2019·2018-10-31

    Siemens StreamLab Refrigerated Storage Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling StreamLab Refrigerated Storage Module 9000 units because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    STREAMLAB - REFRIGERATED STORAGE MODULE 9000
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0215-2019·2018-10-31

    Siemens StreamLab Automation Modules Recalled for Missing Pacemaker Warning Label

    Siemens Healthcare Diagnostics is recalling 186 StreamLab Automation Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    STREAMLAB CORE UNIT / LYNX WITH IOM
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0213-2019·2018-10-31

    Siemens APTIO 9000 Refrigerated Storage Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO 9000 Refrigerated Storage Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO 9000 REFRIGERATED STORAGE MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0214-2019·2018-10-31

    Siemens APTIO Rack Output Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO Rack Output Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO RACK OUTPUT MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0116-2019·2018-10-24

    Siemens Atellica IM CKMB Calibrator Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling 97 kits of Atellica IM CKMB Calibrator due to a potential bias compared to internal standards.

    Product
    Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2019·2018-10-24

    Siemens Recalls Atellica IM 1600 Analyzer Software Due to Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer software version 1.13 and lower due to five identified behavioral issues affecting reagent locking, barcode reading, and result reporting.

    Product
    Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2019·2018-10-24

    Siemens Atellica IM CKMB Master Curve Material Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling Atellica IM CKMB Master Curve Material due to a potential bias identified when compared to internal standards.

    Product
    Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0192-2019·2018-10-24

    Siemens Atellica IM 1300 Analyzer Software Recall for Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.13 and lower due to five identified behavioral issues affecting reagent locks, barcode reading, and result reporting.

    Product
    Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0114-2019·2018-10-24

    Siemens ADVIA Centaur CKMB Calibrator Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling 69 kits of ADVIA Centaur CKMB Calibrator 2-pack Japan due to a potential bias identified compared to internal standards.

    Product
    ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0113-2019·2018-10-24

    Siemens Recalls ADVIA Centaur CKMB Calibrator Kits Due to Potential Bias

    Siemens Healthcare Diagnostics is recalling 1,870 ADVIA Centaur CKMB Calibrator kits due to a potential bias compared to internal standards.

    Product
    ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0115-2019·2018-10-24

    Siemens ADVIA Centaur CKMB Master Curve Material Recalled for Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur CKMB Master Curve Material due to a potential bias identified when compared to internal standards.

    Product
    ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
    Category
    Medical Device
    Distribution
    Distributed nationwide