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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 12 of 3592

Mode Product Rule Evidence excerpt
Device software or design exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy. reason.device_software_design · v1.0.0 software library filtering error
Device software or design Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG reason.device_software_design · v1.0.0 firmware version 6.1.2 can
Device software or design Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly reason.device_software_design · v1.0.0 software defect
Device software or design VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. reason.device_software_design · v1.0.0 software defect
Device software or design Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001) reason.device_software_design · v1.0.0 software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions
Device software or design Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400 reason.device_software_design · v1.0.0 Software 2.51 and Lower with Installed CO2 Measurement Option, may result in
Device software or design TRUMATCH CT PIN 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: 420578 reason.device_software_design · v1.0.0 Software: A coding error
Device software or design 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies. reason.device_software_design · v1.0.0 Software error
Device software or design ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries. reason.device_software_design · v1.0.0 software anomaly
Device software or design basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon. reason.device_software_design · v1.0.0 design issue
Device software or design wDR 2.2 Mobile Digital Diagnostic X-Ray System reason.device_software_design · v1.0.0 software login in issue
Device software or design FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.) reason.device_software_design · v1.0.0 Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may
Device software or design Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD reason.device_software_design · v1.0.0 software to help reduce the incidence of Error
Device software or design EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 reason.device_software_design · v1.0.0 software issue can cause an EchoNavigator error
Device software or design Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A reason.device_software_design · v1.0.0 software problem
Device software or design Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. reason.device_software_design · v1.0.0 software issue
Device software or design TRUMATCH CT CUT GUIDE KIT R- 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: 420916 reason.device_software_design · v1.0.0 Software: A coding error
Device software or design Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for single and biplane diagnostic imaging reason.device_software_design · v1.0.0 software error
Device software or design Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. reason.device_software_design · v1.0.0 software defect
Device software or design reSET 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 ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). reason.device_software_design · v1.0.0 software error
Device software or design ProxiDiagnost N90. radiography and fluoroscopy system reason.device_software_design · v1.0.0 issue in the firmware
Device software or design Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. reason.device_software_design · v1.0.0 issue with software
Device software or design Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 reason.device_software_design · v1.0.0 software defect
Device software or design VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. reason.device_software_design · v1.0.0 software defect

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