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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 9 of 3592

Mode Product Rule Evidence excerpt
Device software or design TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420915 reason.device_software_design · v1.0.0 Software: A coding error
Device software or design EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. reason.device_software_design · v1.0.0 incorrect manufacturing date/timestamp within the software
Device software or design Proteus 235; Version: PTS-8 versions before PTS-8.7.2 reason.device_software_design · v1.0.0 software can
Device software or design TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420917 reason.device_software_design · v1.0.0 Software: A coding error
Device software or design CombiDiagnost R90 Software Version R1.0 and R1.1 reason.device_software_design · v1.0.0 software issue
Device software or design Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP reason.device_software_design · v1.0.0 firmware version 6.1.2 can
Device software or design Alinity m System, Part No. 08N53-002 reason.device_software_design · v1.0.0 software defect
Device software or design t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology reason.device_software_design · v1.0.0 software update. Issues could result in
Device software or design MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 reason.device_software_design · v1.0.0 Software calibration error
Device software or design reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment. reason.device_software_design · v1.0.0 software issue
Device software or design Pentacam HR REF 70900. Used to image the anterior segment of the eye. reason.device_software_design · v1.0.0 software issue
Device software or design 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades reason.device_software_design · v1.0.0 software will result in
Device software or design SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures. reason.device_software_design · v1.0.0 software update will prevent the occurrence of this error
Device software or design CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED). reason.device_software_design · v1.0.0 software issue
Device software or design 728332 IQon Spectral CT-Computed Tomography X-ray system reason.device_software_design · v1.0.0 software will result in
Device software or design 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system reason.device_software_design · v1.0.0 software will result in
Device software or design Azurion systems with software release R1.x reason.device_software_design · v1.0.0 software defect
Device software or design A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001 reason.device_software_design · v1.0.0 software error
Device software or design EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. reason.device_software_design · v1.0.0 incorrect manufacturing date/timestamp within the software
Device software or design 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used. reason.device_software_design · v1.0.0 software defect
Device software or design Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep. reason.device_software_design · v1.0.0 Error in the device firmware
Device software or design icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. reason.device_software_design · v1.0.0 software issue, the display may show the incorrect
Device software or design Clinician Programmer Application (CPA) model A610 Clinician Software Application reason.device_software_design · v1.0.0 software anomaly
Device software or design TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass. reason.device_software_design · v1.0.0 Failure of the LifeSPARC controller when the software
Device software or design t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology reason.device_software_design · v1.0.0 software update. Issues could result in

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