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Recall Observatory FDA recall evidence

Core noun

Failure mode assignments

Deterministic labels derived from preserved recall-reason text.

Indexed record set

89,789 assignments

Page 58 of 3592

Mode Product Rule Evidence excerpt
Device software or design AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. reason.device_software_design · v1.0.0 Software anomaly resulted in failure
Device software or design RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component reason.device_software_design · v1.0.0 firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in
Device software or design Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116 reason.device_software_design · v1.0.0 software R5.7.1 may not provide warning for low ventilation setting which may
Device software or design Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399 reason.device_software_design · v1.0.0 software anomaly may cause re-establishment of incorrect
Device software or design RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component reason.device_software_design · v1.0.0 firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in
Device software or design RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component reason.device_software_design · v1.0.0 firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in
Device software or design StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures. reason.device_software_design · v1.0.0 software anomaly
Device software or design Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117 reason.device_software_design · v1.0.0 software R5.7.1 may not provide warning for low ventilation setting which may
Device software or design ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting reason.device_software_design · v1.0.0 software issue
Device software or design BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. reason.device_software_design · v1.0.0 software issue the device may give false "SpO2 Probe Failure
Device software or design BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01 reason.device_software_design · v1.0.0 error that prevents the user from accessing the dispensing software
Device software or design Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system. reason.device_software_design · v1.0.0 bug in affected iOS software
Device software or design RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component reason.device_software_design · v1.0.0 firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in
Device software or design Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ; reason.device_software_design · v1.0.0 software version 5.3. This issue
Device software or design Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08 reason.device_software_design · v1.0.0 software update will be released to correct issue
Device software or design IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. reason.device_software_design · v1.0.0 software version K.x may experience this issue
Device software or design CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses. reason.device_software_design · v1.0.0 software versions before v4.3, may
Device software or design Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system reason.device_software_design · v1.0.0 Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can
Device software or design IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. reason.device_software_design · v1.0.0 software version K.x may experience this issue
Device software or design DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. reason.device_software_design · v1.0.0 software bug issues with the analyzer. Issue
Device software or design IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. reason.device_software_design · v1.0.0 software version K.x may experience this issue
Device software or design StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. reason.device_software_design · v1.0.0 software anomalies
Device software or design IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. reason.device_software_design · v1.0.0 software version K.x may experience this issue
Device software or design BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. reason.device_software_design · v1.0.0 Software anomaly
Device software or design Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral vascular imaging catheter, the system utilizes the IVUS modality for ultrasound examination of intravascular pathology. reason.device_software_design · v1.0.0 software anomaly

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