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.

176–200 of 276

ModerateFDA (Devices)·Z-1971-2015·2015-07-08
Tecan Infinite 200 Microplate Reader Recalled for Firmware Bug
Tecan US, Inc. is recalling 868 Infinite 200 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.
Product
Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1957-2015·2015-07-08
Siemens CentraLink Data Management System Software Recall
Siemens recalls CentraLink software because the sample query function may fail to return all samples from Dimension Vista systems under specific configurations.
Product
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2015·2015-07-08
Tecan Infinite F500 Microplate Reader Recalled for Firmware Bug
Tecan US, Inc. is recalling 868 Infinite F500 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.
Product
Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1942-2015·2015-07-08
Siemens EasyLink Data Management System Recalled for Software Limitations
Siemens Healthcare Diagnostics is recalling 1,355 units of the EasyLink Data Management System due to software issues affecting reference ranges and sample actions.
Product
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1796-2015·2015-06-24
Mortara ELI 380 Electrocardiograph Recalled for Patient Data Mismatch Risk
Mortara Instrument is recalling 176 ELI 380 electrocardiographs because ECG waveforms may be incorrectly associated with the wrong patient's demographics when transmitted to records systems.
Product
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, prin
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-1807-2015·2015-06-24
Philips Q-Station Ultrasound Software Recalled for Data Integrity Issues
Philips is recalling Q-Station ultrasound software because patient measurements may be incorrectly appended to other patients' studies.
Product
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is desig
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1705-2015·2015-06-10
Siemens Medical Software Recall for Missing Image Measurements on Printouts
Siemens Medical Solutions is recalling 167 units of Syngo.via and Syngo.x software because measurements on subsequent images do not appear on printouts.
Product
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1692-2015·2015-06-10
Smiths Medical Recalls BCI Advisor Vital Signs Monitors for Data Errors
Smiths Medical is recalling 15 BCI Advisor Vital Signs Monitors because their auxiliary serial ports may transmit incorrect data to collection systems.
Product
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1611-2015·2015-05-20
Fujifilm Synapse Cardiovascular Software Recalled for Inaccurate EMR Measurements
Fujifilm Medical Systems is recalling Synapse Cardiovascular software because measurement values in the EMR may not match clinical reports.
Product
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-1612-2015·2015-05-20
Fujifilm Synapse Cardiovascular Software Recall for Patient Demographic Mismatch
Fujifilm Medical Systems is recalling Synapse Cardiovascular software versions v4.0.8 and v4.0.8 SR1 because patient demographics in exported reports may not match the clinical reports.
Product
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1354-2015·2015-04-08
Siemens Syngo.plaza PACS Recalled for Incomplete Archived Studies
Siemens Medical Solutions is recalling four Syngo.plaza PACS units because they may leave partially archived studies unarchived during pre-fetch operations.
Product
Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-1228-2015·2015-03-11
Medtronic CareLink Pro Software Recall for Inaccurate Basal Data Display
Medtronic MiniMed is recalling CareLink Pro and CareLink Clinical software due to a defect that may cause inaccurate display of Temp Basal time and duration in reports.
Product
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physic
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1065-2015·2015-02-18
SCC Soft Computer Recalls SoftPath Laboratory Information System Versions
SCC Soft Computer is recalling specific versions of the SoftPath Laboratory Information System because diagnostic text modifications may not be saved or displayed correctly.
Product
SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2015·2015-01-21
Siemens ADVIA Chemistry XPT Software Recall for Result Overwrite Risk
Siemens is recalling 7 ADVIA Chemistry XPT systems in Washington due to a software defect that may cause critical results to be overwritten.
Product
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLin
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0910-2015·2015-01-14
McKesson Cardiology ECG Management Software Recalled for Incorrect Time Stamps
McKesson Israel Ltd. is recalling McKesson Cardiology ECG Management software versions 13.1 and 13.1.1 because a software error causes incorrect ECG procedure time stamps.
Product
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0856-2015·2014-12-31
Horiba Lite DM Software Recall for Potential Data Mismatch
Horiba Instruments is recalling Lite DM software versions 2.0.0.19 and lower due to a bug that may apply test results to the wrong patient order.
Product
Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0849-2015·2014-12-31
Illumina MiSeqDx Universal Kit 1.0 Recalled for Software Limitation
Illumina Inc is recalling 13 units of the MiSeqDx Universal Kit 1.0 because a software limitation prevents the reporting of specific genomic insertions and deletions.
Product
Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sampl
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2637-2014·2014-09-24
Data Innovations Recalls ProVue Instrument Driver for JResultNet Software
Data Innovations, LLC is recalling ProVue Instrument Driver for JResultNet versions 1.5.3 and below because the software may misassociate data with patient results.
Product
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2653-2014·2014-09-24
Mitsubishi Vero Linear Accelerator Software Recall for Treatment Status Errors
Mitsubishi Heavy Industries is recalling three Vero Linear Accelerator systems in the US due to a software defect that may incorrectly mark completed radiation treatments as untreated.
Product
VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2665-2014·2014-09-24
Siemens CentraLink Data Management System Software Recall for Timer Overflow
Siemens is recalling CentraLink Data Management System software version 14 due to a task scheduler issue that may stop command execution and result uploads.
Product
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2561-2014·2014-09-10
Siemens EasyLink Informatics System Recall for Potential Result Transmission Errors
Siemens Healthcare Diagnostics is recalling the EasyLink Informatics System V4.0/V5 because it may release results to the Laboratory Information System that should have been held for manual review.
Product
Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2563-2014·2014-09-10
Roche cobas IT 1000 Recalled for Potential Patient ID Mismatch
Roche Diagnostics is recalling 148 cobas IT 1000 devices because they may assign test results to the wrong patient ID if specific system messages are received.
Product
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2252-2014·2014-08-27
Philips IntelliSpace PACS 4.4 Software Recall for Data Integrity Issues
Philips is recalling IntelliSpace PACS 4.4 software because a defect may cause incomplete patient data to be exported, potentially affecting diagnosis.
Product
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2267-2014·2014-08-27
Intelerad IntelePACS Software Recall Due to Potential File Truncation Errors
Intelerad Medical Systems is recalling IntelePACS software versions 3-8-1 to 4-9-1 because partially truncated files may be incorrectly reported as complete.
Product
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2140-2014·2014-08-13
Ortho VITROS 4600 Chemistry System Recalled for Software Error
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may associate incorrect patient demographics with sample IDs.
Product
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, r
Category
Medical Device
Distribution
Distributed nationwide