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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 56 of 3592

Mode Product Rule Evidence excerpt
Device software or design SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system reason.device_software_design · v1.0.0 Software error
Device software or design Merlin PCS 3650 programmer Model 3330 software reason.device_software_design · v1.0.0 software anomaly
Device software or design ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. reason.device_software_design · v1.0.0 Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may
Device software or design Ultraview SL (UVSL) Command Module, Model 91496 reason.device_software_design · v1.0.0 software version: 1) Older versions will
Device software or design The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator. reason.device_software_design · v1.0.0 software anomalies
Device software or design ZAP-X Radiosurgery System reason.device_software_design · v1.0.0 Software issue
Device software or design VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9 reason.device_software_design · v1.0.0 software anomalies
Device software or design Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E reason.device_software_design · v1.0.0 Software anomalies
Device software or design cobas e801 Immunoassay Analyzer reason.device_software_design · v1.0.0 Software issue
Device software or design The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator. reason.device_software_design · v1.0.0 software anomalies
Device software or design DigitalDiagnost C50 1.1 reason.device_software_design · v1.0.0 issue in the firmware
Device software or design Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A reason.device_software_design · v1.0.0 Software anomalies
Device software or design Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B reason.device_software_design · v1.0.0 Software anomalies
Device software or design 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR reason.device_software_design · v1.0.0 Software version 2.74 upgrade and (2)hardware related cause
Device software or design Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620 reason.device_software_design · v1.0.0 software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may
Device software or design Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D reason.device_software_design · v1.0.0 Software anomalies
Device software or design cobas infinity central lab, Material Number 07154003001 reason.device_software_design · v1.0.0 software bug
Device software or design Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w reason.device_software_design · v1.0.0 software issues may result in
Device software or design BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 reason.device_software_design · v1.0.0 software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in
Device software or design BD Pyxis MedBank System - Product Label/labeling pending reason.device_software_design · v1.0.0 software which may
Device software or design Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C reason.device_software_design · v1.0.0 Software anomalies
Device software or design Spectral CT on Rails: Software Version 5.1.0.X, model 728334. reason.device_software_design · v1.0.0 software issue
Device software or design Alinity ci-series System Control Module, REF: 03R70-01 reason.device_software_design · v1.0.0 software versions 3.4.0 and lower, including: 1) SCC Reagent load error
Device software or design Flow-c Anesthesia System, model 6887700 reason.device_software_design · v1.0.0 cybersecurity vulnerability
Device software or design Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus. ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus. reason.device_software_design · v1.0.0 software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will

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