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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 18 of 3592

Mode Product Rule Evidence excerpt
Device software or design ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. reason.device_software_design · v1.0.0 firmware of the Interface Modules and the Automation software. This problem
Device software or design Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20 reason.device_software_design · v1.0.0 Software issue
Device software or design ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R. reason.device_software_design · v1.0.0 issue that affects certain systems that use the recalled software
Device software or design Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715 reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213 reason.device_software_design · v1.0.0 anomaly is present in InoqulA / InoqulA+ software
Device software or design AIA-360 Automated Immunoassay Analyzer, Product Code 019945 reason.device_software_design · v1.0.0 software issue
Device software or design SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve. reason.device_software_design · v1.0.0 software using the supplied USB drive, an error
Device software or design Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially. reason.device_software_design · v1.0.0 software error
Device software or design HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities. reason.device_software_design · v1.0.0 software error
Device software or design ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 reason.device_software_design · v1.0.0 software security vulnerabilities with the firm's analyzer operating system, which may cause
Device software or design HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities. reason.device_software_design · v1.0.0 software error
Device software or design BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202 reason.device_software_design · v1.0.0 anomaly is present in InoqulA / InoqulA+ software
Device software or design HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities. reason.device_software_design · v1.0.0 software error

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