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    MedTech Cybersecurity · Since 2022

    Goat Feed · Topic

    #gray-zone

    Items tagged #gray-zone

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    infoSoftware QualityNov 3, 2026 · 13:00 UTC

    FDA Recall: Boston Scientific Neuromodulation Corporation, Stimulator, Spinal-Cord, Implanted (Pain Relief)

    Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading it to become non-functional, and if a secondary TD is…

    infoSoftware QualityOct 30, 2026 · 13:00 UTC

    FDA Recall: Abiomed, Inc., Temporary Non-Roller Type Left Heart Support Blood Pump

    Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may…

    infoSoftware QualityOct 30, 2026 · 13:00 UTC

    FDA Recall: BioMerieux SA, Clinical Sample Concentrator

    Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2

    infoSoftware QualityOct 30, 2026 · 13:00 UTC

    FDA Recall: Abiomed, Inc., Temporary Non-Roller Type Left Heart Support Blood Pump

    Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may…

    infoSoftware QualityOct 30, 2026 · 13:00 UTC

    FDA Recall: Abiomed, Inc., Temporary Non-Roller Type Left Heart Support Blood Pump

    Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may…

    infoSoftware QualityOct 13, 2026 · 13:00 UTC

    FDA Recall: Ferno-Washington Inc, Stretcher, Wheeled

    Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered performance. Issue may result in interruption or delay in…

    infoSoftware QualitySep 26, 2026 · 19:48 UTC

    FDA Recall: Abiomed, Inc., Temporary Non-Roller Type Left Heart Support Blood Pump

    Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to…

    infoSoftware QualityJul 24, 2026 · 13:00 UTC

    FDA Recall: Boston Scientific Corporation, System, Image Processing, Radiological

    Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that…

    infoSoftware QualityJun 29, 2026 · 02:24 UTC

    FDA Recall: IPG Medical Corporation, Powered Laser Surgical Instrument

    Software anomaly that causes a false display of error code 5018.

    infoSoftware QualityJun 21, 2026 · 21:41 UTC

    FDA Recall: Unknown manufacturer, Full-Montage Standard Electroencephalograph

    Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second…

    infoSoftware QualityJun 21, 2026 · 21:40 UTC

    FDA Recall: Medtronic Navigation, Inc.-Boxborough, Interventional Fluoroscopic X-Ray System

    Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.