The Recall Desk

Hazard

Incorrect Data recalls

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

What the numbers show

Total
50
Critical
0
Severe
0
Most recent
2020-11-04

Of the 50 incorrect data recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 incorrect data 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.

26–50 of 50

  • HighFDA (Devices)·Z-2341-2016·2016-08-10

    Merge HEMO software recall for inaccurate INR display

    Merge Healthcare is recalling 37 units of Merge HEMO software because the displayed International Normalized Ratio (INR) value does not match the imported value.

    Product
    Merge HEMO software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2245-2016·2016-07-27

    Siemens Syngo.via PACS Software Recalled for Incorrect Volume Calculations

    Siemens Medical Solutions is recalling 50 units of Syngo.via PACS software due to incorrect volume calculation values. A software update is available to resolve the error.

    Product
    Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2016·2016-07-06

    CareFusion Alaris System PC Unit Recall for Incorrect Patient Weight Data

    CareFusion 303, Inc. is recalling 69,693 Alaris System PC Units because the RESTORE feature may incorrectly populate patient weight for specific infusion modules.

    Product
    Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2016·2016-05-18

    Novarad NovaPACS Diagnostic Viewer Recalled for Incorrect SUV Calculations

    Novarad Corporation is recalling specific versions of NovaPACS Diagnostic Viewer because the PET/CT fusion tool calculates incorrect SUV values.

    Product
    NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2016·2015-12-09

    Carl Zeiss IOL Master 5.5 Software Recall for Incorrect Data

    Carl Zeiss Meditec AG is recalling IOL Master 5.5 software versions 7.5 and 7.7 because printouts and reports may contain incorrect IOL power data.

    Product
    IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2015·2015-07-08

    Tecan Infinite M1000 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite M1000 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2015·2015-07-08

    Tecan Infinite M1000 PRO Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite M1000 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2015·2015-05-06

    Fresenius 2008K2 Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008K2 hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2015·2015-02-04

    Mobius Airo Mobile Intraoperative CT System Recalled for Data Transfer Errors

    Mobius Imaging is recalling 21 Airo Mobile Intraoperative CT systems because a software error may cause incorrect or missing navigation data to transfer to the Brainlab Curve system.

    Product
    Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1000-2015·2015-01-28

    BD Biosciences Recalls Contaminated CD8 PE In Vitro Diagnostic Reagent

    BD Biosciences is recalling one lot of CD8 PE reagent contaminated with CD4 FITC, which may cause incorrect patient data.

    Product
    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2015·2014-11-26

    Elekta MOSAIQ Oncology System Recalled for Dose Rounding Error

    Elekta, Inc. is recalling 15 units of the MOSAIQ oncology information system because a dose rounding error may cause incorrect numeric data to be displayed on printed reports.

    Product
    MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2609-2014·2014-09-17

    Ab Sciex API 3200MD System Recalled for Incorrect Diagnostic Data

    Ab Sciex is recalling six API 3200MD LC/MS/MS systems because the MultiQuant 3.0 software may provide incorrect data for patient diagnosis.

    Product
    AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2586-2014·2014-09-10

    Spacelabs Ariatele Telemetry Transmitter Recalled for SpO2 Display Errors

    Spacelabs is recalling Ariatele Telemetry Transmitters because they may display SpO2 values when sensors are disconnected or failed.

    Product
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2237-2014·2014-08-20

    Philips Recalls IntelliSpace Portal Software Due to MUGA Scan Display Error

    Philips Medical Systems is recalling IntelliSpace Portal software versions DX/HX/EX, IX, and LX SPECT because reopening MUGA scan bookmarks may display incorrect ejection fraction values.

    Product
    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterpr
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2077-2014·2014-07-23

    Spacelabs Ultraview SL Multigas Module Recalled for Invalid MAC Display

    Spacelabs Healthcare is recalling 8 Ultraview SL Multigas Modules because the software displays an invalid Minimum Alveolar Concentration value.

    Product
    Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1495-2014·2014-04-30

    Philips MDC PACS and IntelliSpace PACS DCX Software Recall for Density Errors

    Philips is recalling MDC PACS and IntelliSpace PACS DCX software because it may display incorrect density measurements on Enhanced CT and MR examinations.

    Product
    Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliS
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2241-2013·2013-09-25

    GE Healthcare recalls READY View fMRI software due to incorrect maps

    GE Healthcare is recalling READY View software because it may compute and display incorrect fMRI activation maps.

    Product
    GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1050-2013·2013-04-10

    Horiba Medical Recalls ABX Micros IM2 Data Management System

    Horiba Medical is recalling 180 units of the ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.

    Product
    ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0994-2013·2013-04-03

    Toshiba Infinix-i X-Ray System Recalled for Software Image Error

    Toshiba is recalling 95 Infinix-i X-Ray systems because a software error may display incorrect images or cause image loss during fluoroscopy.

    Product
    Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0694-2013·2013-01-23

    Spacelabs Smart Disclosure System Recalled for Incorrect Waveform Display

    Spacelabs Healthcare is recalling the Smart Disclosure System, Model 92810, because it may display or print incorrect patient waveforms for the indicated time.

    Product
    Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0252-2013·2012-11-14

    Diagnostica Stago STA Satellite Analyzer Recalled for Incorrect INR Printouts

    Diagnostica Stago is recalling 237 STA Satellite Automated Multi-Parameter Analyzers because they may print incorrect INR values when using an external printer.

    Product
    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant ther
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2013·2012-11-07

    Vital Images Recalls Vitrea Software Due to Calcium Score Errors

    Vital Images is recalling Vitrea software versions due to potential errors in calcium score values within restored study snapshots.

    Product
    Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea En
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2012·2012-09-05

    Cisco HealthPresence Software Recall for Vital Signs Display Errors

    Cisco Systems is recalling HealthPresence software version 2.1 because subsequent vital signs readings may not update correctly in the OnePlace tab, potentially leading to incorrect interpretations.

    Product
    Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco Heal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2012·2012-08-15

    Siemens syngo Lab Data Manager Recall for Incorrect Coagulation Results

    Siemens is recalling 15 syngo Lab Data Manager units because they may display and transmit incorrect coagulation results to laboratory information systems.

    Product
    Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2012·2012-07-18

    Elekta Monaco Software Recall for Incorrect Patient Shift Directions

    Elekta, Inc. is recalling Monaco radiation therapy planning software versions 3.10.00 through 3.20.00 due to a defect that prints incorrect patient shift directions when specific DICOM options are enabled.

    Product
    Monaco Product Usage: Planning of radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide