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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 11 of 3592

Mode Product Rule Evidence excerpt
Device software or design Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories. reason.device_software_design · v1.0.0 defect (hardware and software
Device software or design PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A reason.device_software_design · v1.0.0 firmware and the Automation software without any error
Device software or design ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system. reason.device_software_design · v1.0.0 Software anomalies
Device software or design Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) reason.device_software_design · v1.0.0 software revision may fail to detect air in line, which may
Device software or design VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0 reason.device_software_design · v1.0.0 software version, the user could
Device software or design VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 reason.device_software_design · v1.0.0 software version, the user could
Device software or design Aptio Automation Storage and Retrieval Module (SRM) reason.device_software_design · v1.0.0 firmware error may lead to an incorrect
Device software or design Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft). reason.device_software_design · v1.0.0 software error
Device software or design RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0 reason.device_software_design · v1.0.0 issue was found in Software
Device software or design SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit. reason.device_software_design · v1.0.0 software update (v1.1.5) has been developed to address the issue
Device software or design Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids. reason.device_software_design · v1.0.0 software error
Device software or design Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view reason.device_software_design · v1.0.0 Software error
Device software or design Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255 reason.device_software_design · v1.0.0 software/network cards/IP addresses can have network/wireless connection failure. Could cause
Device software or design Getinge Flow-c Anesthesia System, Part No. 6887700 reason.device_software_design · v1.0.0 software bug
Device software or design Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly reason.device_software_design · v1.0.0 software defect
Device software or design Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD reason.device_software_design · v1.0.0 software issue, New systems may exhibit an error
Device software or design VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0 reason.device_software_design · v1.0.0 software version, the user could
Device software or design Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000 reason.device_software_design · v1.0.0 software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack causes
Device software or design Functional MR V1.0 reason.device_software_design · v1.0.0 software bug
Device software or design Programmable Diagnostic Computer reason.device_software_design · v1.0.0 software update to address a software error
Device software or design ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of patients during clinical applications Material Number: 10308194 reason.device_software_design · v1.0.0 Software issue
Device software or design EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359 reason.device_software_design · v1.0.0 software issue
Device software or design Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400 reason.device_software_design · v1.0.0 software bug
Device software or design Getinge Flow-e Anesthesia System, Part No. 6887900 reason.device_software_design · v1.0.0 software bug
Device software or design Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F) reason.device_software_design · v1.0.0 design error

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