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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 4 of 3592

Mode Product Rule Evidence excerpt
Device software or design BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 reason.device_software_design · v1.0.0 software issue
Device software or design BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system reason.device_software_design · v1.0.0 software issue
Device software or design Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 reason.device_software_design · v1.0.0 software issue
Device software or design Baxter Mobile column TruSystem 7500 U, Product Code 1730720 reason.device_software_design · v1.0.0 software issue
Device software or design Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1. reason.device_software_design · v1.0.0 software issue
Device software or design Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05 reason.device_software_design · v1.0.0 Software Error #3 (SE3) error
Device software or design BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9 reason.device_software_design · v1.0.0 software issue
Device software or design Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z reason.device_software_design · v1.0.0 defect in the air-in-line software
Device software or design NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software reason.device_software_design · v1.0.0 Cybersecurity vulnerability
Device software or design Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component reason.device_software_design · v1.0.0 software versions 3.8.0 may
Device software or design Z1 Femoral Hip System, Product Number 611777612 reason.device_software_design · v1.0.0 design issue
Device software or design Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; 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
Device software or design EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231 reason.device_software_design · v1.0.0 software defect
Device software or design Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; 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
Device software or design BD Pyxis MedBank MedPass Software, REF: 139088-01 reason.device_software_design · v1.0.0 software may continue to show the already dispensed medication dose is still available for dispense, which could
Device software or design Baxter Mobile column TruSystem 7500, Product Code 1717023 reason.device_software_design · v1.0.0 software issue
Device software or design The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes). reason.device_software_design · v1.0.0 software may not detect an issue
Device software or design Baxter Floor mounting column TruSystem 7500, Product Code 1717021 reason.device_software_design · v1.0.0 software issue
Device software or design Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088 reason.device_software_design · v1.0.0 software issue
Device software or design BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system reason.device_software_design · v1.0.0 software issue

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