The Recall Desk

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.

251–275 of 276

  • HighFDA (Devices)·Z-0880-2013·2013-03-06

    Philips Brilliance CT Scanners Recalled for Software Data Flipping Error

    Philips is recalling Brilliance CT scanners because a software anomaly causes Intensity Projection datasets to be flipped and incorrectly labeled left-to-right.

    Product
    Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0881-2013·2013-03-06

    Philips Medical Systems Recalls Extended Brilliance Workspace X-Ray Scanners

    Philips Medical Systems is recalling 39 Extended Brilliance Workspace X-Ray Scanners because a software anomaly may cause generated data sets to be flipped and incorrectly labeled.

    Product
    Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0882-2013·2013-03-06

    Philips GEMINI PET/CT Systems Recalled for Software Data Flipping Error

    Philips is recalling 30 GEMINI PET/CT systems because a software error causes Intensity Projection data to be flipped and mislabeled left-to-right.

    Product
    Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0645-2013·2013-01-16

    Horiba Medical Recalls ABX PENTRA ML Software Due to Data Validation Error

    Horiba Medical is recalling ABX PENTRA ML software versions V8.0.x and below, V9.0.1, and V9.0.2 because a rare data management issue may transmit incorrect patient results to the Laboratory Information System.

    Product
    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2013·2013-01-09

    Mindray DPM Central Station Recalled for Patient Data Anomaly

    Mindray is recalling two DPM Central Station units due to a software anomaly that may replace one patient's trend data with another's.

    Product
    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2013·2013-01-09

    Abbott m2000sp Instrument Software Recall for Data Saving Error

    Abbott Molecular is recalling m2000sp Instruments due to a software issue where changes to control or calibrator information are not saved.

    Product
    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2013·2012-12-26

    Varian ARIA Radiation Oncology System Recall for DICOM Export Anomaly

    Varian Medical Systems is recalling ARIA Oncology Information System units due to a software anomaly where 360-degree arc fields may convert to static fields during DICOM import or export.

    Product
    Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured an
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0251-2013·2012-11-14

    Sunquest Phlebotomy Interface Software Recall for Inappropriate Order Combination

    Sunquest Information Systems is recalling 9 units of its Outbound Phlebotomy Point of Care Interface software due to confirmed reports of inappropriate patient order combination.

    Product
    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0250-2013·2012-11-14

    Sunquest Laboratory Version 7.0 Recalled for Data Integrity Errors

    Sunquest Information Systems is recalling Sunquest Laboratory version 7.0 because a software defect can cause user-defined data to be incorrectly replaced.

    Product
    Sunquest Laboratory, version 7.0 not available
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2013·2012-10-31

    Elekta Recalls Oncentra External Beam 4.1 Radiation Treatment Planning Software

    Elekta, Inc. is recalling 52 units of Oncentra External Beam 4.1 software due to a defect that allows beam weights to be changed during dose calculation without error messages.

    Product
    Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0048-2013·2012-10-17

    Siemens syngo.plaza Radiological Image Processing System Recall

    Siemens is recalling 11 syngo.plaza systems due to a software defect where archived studies may be missing from the database.

    Product
    Siemens syngo.plaza radiological image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2463-2012·2012-10-03

    DEXIS Imaging Suite Software Recall for Patient Data Mixing

    Imaging Sciences International is recalling DEXIS Imaging Suite software versions 10.0.0 through 10.0.3 due to a defect that can mix patient records during database renumbering.

    Product
    DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-2270-2012·2012-09-05

    Sunquest Laboratory Software Recall for Microbiology Data Entry Errors

    Sunquest Information Systems is recalling Sunquest Laboratory software versions 6.4 and later due to potential errors in specimen data entry.

    Product
    Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2229-2012·2012-08-29

    Sunquest Laboratory SMART Software Recall for Incorrect Patient Data

    Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.4.2 due to a defect that may display incorrect patient demographic data.

    Product
    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2238-2012·2012-08-29

    McKesson Horizon Medical Imaging System Recalled for Incorrect Report Status

    McKesson Medical Imaging Group is recalling Horizon Medical Imaging systems because reports may be saved with an incorrect final status.

    Product
    Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2012·2012-08-22

    AGFA IMPAX Cardiovascular Reporting Software Recalled for Missing Report Data

    AGFA Corp. is recalling IMPAX Cardiovascular Reporting software because user-entered conclusions were not printed on final reports.

    Product
    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2216-2012·2012-08-22

    Sunquest Laboratory SMART Software Recalled for Test Result Filing Errors

    Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.3.0 and later because test results may be filed to the wrong patient containers.

    Product
    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2153-2012·2012-08-15

    Varian ARIA Oncology Software Recall Due to Incorrect MLC Data Import

    Varian Medical Systems is recalling two units of ARIA Oncology Information System software due to a defect that incorrectly imports MLC leaf positions for specific treatment plans.

    Product
    Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2012·2012-08-15

    Radiometer ABL90 FLEX Software Recall for HL7 Data Transmission Errors

    Radiometer America Inc. is recalling ABL90 FLEX software version 2.7 MR3 because a data transfer error can cause mixed-up results when transmitting to hospital systems.

    Product
    ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2162-2012·2012-08-15

    Radiometer ABL800 Software Recall for HL7 Data Transmission Errors

    Radiometer America is recalling ABL800 software version 6.12 because HL7 2.5 configuration errors may cause queued blood test results to be mixed up when transmitted to hospital systems.

    Product
    The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2143-2012·2012-08-15

    SCC Soft Computer Recalls SoftLab Laboratory Information System Software

    SCC Soft Computer is correcting SoftLab software versions that incorrectly displayed results from two different Sysmex hematology instruments under a single order.

    Product
    SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2012·2012-08-01

    Siemens syngo.plaza Radiological Image Processing System Recalled for Malfunction

    Siemens is recalling two syngo.plaza radiological image processing systems due to a potential malfunction where images may fail to load without an error message.

    Product
    Siemens syngo.plaza. Radiological image processing system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1942-2012·2012-07-11

    Philips Xcelera Connect Software Recalled for Incomplete Data Exchange

    Philips Healthcare is recalling 226 units of Xcelera Connect software because unformatted reports may result in incomplete information arriving at the interface.

    Product
    Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM).
    Category
    Medical Device
    Distribution
    Distributed nationwide