Hazard

Data Integrity recalls

276 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 276
Critical: 0
Severe: 9
Most recent: 2026-08-19

Of the 276 data integrity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (3%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all data integrity recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

151–175 of 276

ModerateFDA (Devices)·Z-1575-2016·2016-05-04
Mindray Panorama Patient Monitoring Network Recalled for Date Reversion
Mindray DS USA is recalling Panorama Patient Monitoring Network units that may revert to the year 2000 during Daylight Savings Time.
Product
Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside mo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1501-2016·2016-04-27
Medtronic Recalls CareLink iPro2 Reports Due to Time Zone Error
Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because they used the wrong time zone, causing inaccurate timestamps for continuous glucose data.
Product
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1282-2016·2016-04-06
Siemens Artis One X-Ray System Recalled for Data Mirroring Error
Siemens is recalling one Artis One angiography system because imported left atrium segmentation results may be incorrectly mirrored to a 3D mapping system.
Product
Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardia
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1269-2016·2016-04-06
Beckman Coulter Recalls MicroScan LabPro Software Due to Editing Error
Beckman Coulter is recalling MicroScan LabPro software because it allows incorrect manual editing of carbohydrate substrates for specific test panels.
Product
MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update K
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1092-2016·2016-03-16
Spacelabs Xhibit Central Station Recalled for Height and Weight Input Error
Spacelabs Healthcare is recalling Xhibit Central Station units because patient height and weight values may be switched, causing incorrect Body Surface Area calculations.
Product
Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-0826-2016·2016-03-02
Siemens Syngo Dynamics Software Recalled for Potential Patient Data Mixing
Siemens is recalling Syngo Dynamics PACS software because it may mix data from multiple patients in echo trend graphs.
Product
software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0857-2016·2016-03-02
Philips PIIC Classic Upgrade Patient Monitor Recall for ECG Waveform Misrepresentation
Philips is recalling PIIC Classic Upgrade patient monitors because reconstructed ECG leads may misrepresent waveforms on the Information Center iX.
Product
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0858-2016·2016-03-02
Philips IntelliVue Info Center iX Recalled for ECG Waveform Misrepresentation
Philips is recalling IntelliVue Info Center iX monitors because reconstructed ECG leads may misrepresent waveforms, potentially affecting clinical interpretation.
Product
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0748-2016·2016-02-10
Radiometer AQURE System Recalled for Sample Type Design Error
Radiometer America Inc is recalling 375 AQURE Systems (Model 933-599) because a design error may leave the sample type field blank, potentially leading to misinterpretation of blood gas and immunoassay results.
Product
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0426-2016·2015-12-23
bioMerieux MYLA Software Recall for Potential Patient Record Mismatch
bioMerieux is recalling MYLA software due to a potential risk of linking test results to incorrect patient records.
Product
MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0431-2016·2015-12-23
bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors
bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.
Product
MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0430-2016·2015-12-23
bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors
bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.
Product
MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0427-2016·2015-12-23
bioMerieux MYLA Clinic Patch 3.3.0 Recalled for Patient Data Linking Error
bioMerieux is recalling MYLA Clinic Patch 3.3.0 software because it may link test results to incorrect patient records when connected to specific laboratory systems.
Product
MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0429-2016·2015-12-23
bioMerieux Recalls MYLA Software Due to Patient Data Linking Error
bioMerieux is recalling MYLA software because it may link test results to the wrong patient record when connected to specific laboratory systems.
Product
MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0434-2016·2015-12-23
Beckman Coulter Recalls DxH Slidemaker Stainer Software Due to ID Errors
Beckman Coulter is recalling specific software versions for the DxH 600 and 800 Slidemaker Stainer systems because they allow the creation of multiple orders with the same specimen ID but different patient IDs.
Product
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a v
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0428-2016·2015-12-23
bioMerieux MYLA Software Recalled for Potential Patient Record Mismatch
bioMerieux is recalling MYLA software due to a potential risk of linking test results to incorrect patient records when connected to specific laboratory systems.
Product
MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0433-2016·2015-12-23
Beckman Coulter Recalls DxH 800 and DxH 600 Software Versions
Beckman Coulter is recalling specific software versions for its DxH 800 and DxH 600 hematology analyzers because the systems allow multiple orders to share the same specimen ID with different patient IDs.
Product
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical labora
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0432-2016·2015-12-23
Beckman Coulter Recalls DxH 800 and 600 Hematology Analyzer Software
Beckman Coulter is recalling specific software versions for its DxH 800 and DxH 600 hematology analyzers because the software allows the creation of multiple orders with the same specimen ID but different patient IDs.
Product
UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0283-2016·2015-11-25
Agfa Healthcare Recalls IMPAX CV Software for Incorrect PDF Reports
Agfa Healthcare is recalling IMPAX CV software versions 7.8.x and 12.x because the Demographics Manager feature may generate incorrect PDF reports after physician signature.
Product
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0023-2016·2015-10-14
GE Healthcare Recalls Centricity PACS IW Due to Missing Images
GE Healthcare is recalling 921 Centricity PACS IW systems worldwide because images may be missing when a specific system parameter is set to a value greater than 1.
Product
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2479-2015·2015-09-09
Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Data Integrity Issues
Siemens is recalling RAPIDPoint 500 Blood Gas Analyzers because simultaneous use of Serial and Ethernet ports may cause data duplication, loss, or patient mismatch.
Product
RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2491-2015·2015-09-09
Philips Ingenuity TF PET/MR Systems Recalled for Potential Database Lockup
Philips is recalling 11 Ingenuity TF PET/MR systems because the PET Reconstruction Server database may lock up between scans, though no field issues have been reported.
Product
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2263-2015·2015-08-05
McKesson Paragon Laboratory Management Software Recall for Data Display Errors
McKesson Technologies is recalling Paragon Laboratory Management software versions 12.1 and 12.1.1 because the Final Cumulative Report may display incorrect data when used with Microsoft SQL Server 2012.
Product
Paragon Laboratory Management
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2061-2015·2015-07-22
Agfa Healthcare Recalls Two IMPAX Agility Medical Imaging Systems
Agfa Healthcare is recalling two IMPAX Agility PACS units in Missouri due to a software error that displayed incorrect patient names.
Product
IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, repor
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2044-2015·2015-07-15
Volcano Intravascular Ultrasound System Recalled for Interoperability Limitation
Volcano Corp is recalling 227 Intravascular Ultrasound Imaging and Pressure Systems due to a limitation in interoperability with the Philips Xper Flex Cardia system that may impact Fraction Flow Reserve calculations.
Product
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structu
Category
Medical Device
Distribution
Distributed nationwide