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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 57 of 3592

Mode Product Rule Evidence excerpt
Device software or design Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. reason.device_software_design · v1.0.0 software bug
Device software or design Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w reason.device_software_design · v1.0.0 software issues may result in
Device software or design Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w reason.device_software_design · v1.0.0 software issues may result in
Device software or design Flow-i C40 Anesthesia System, model 6677400 reason.device_software_design · v1.0.0 cybersecurity vulnerability
Device software or design Flow-e Anesthesia System, model 6887900 reason.device_software_design · v1.0.0 cybersecurity vulnerability
Device software or design Flow-i C20 Anesthesia System, model 6677200 reason.device_software_design · v1.0.0 cybersecurity vulnerability
Device software or design 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller. reason.device_software_design · v1.0.0 software and controller systems that results in
Device software or design VITROS XT 7600 Integrated System, Catalog No. 6844461 reason.device_software_design · v1.0.0 software defect
Device software or design VITROS XT 3400 Chemistry System, Catalog No. 6844458 reason.device_software_design · v1.0.0 software defect
Device software or design VITROS XT 3400 Chemistry System, Catalog No. 6844458 reason.device_software_design · v1.0.0 software defect
Device software or design Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340. reason.device_software_design · v1.0.0 software issue
Device software or design VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) reason.device_software_design · v1.0.0 software defect
Device software or design VITROS XT 7600 Integrated System, Catalog No. 6844461 reason.device_software_design · v1.0.0 software defect
Device software or design Flow-i C30 Anesthesia System, model 6677300 reason.device_software_design · v1.0.0 cybersecurity vulnerability
Device software or design Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF reason.device_software_design · v1.0.0 software version 5.2.05, the alarm volume may
Device software or design Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. reason.device_software_design · v1.0.0 Software v1.23.2 and lower-may
Device software or design VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) reason.device_software_design · v1.0.0 software defect
Device software or design VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) reason.device_software_design · v1.0.0 software defect
Device software or design VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) reason.device_software_design · v1.0.0 software defect
Device software or design VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) reason.device_software_design · v1.0.0 software defect
Device software or design VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) reason.device_software_design · v1.0.0 software defect
Device software or design Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures reason.device_software_design · v1.0.0 software bug
Device software or design CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product numbers cover the three different configurations in which the CORI Console is sold reason.device_software_design · v1.0.0 Software exhibits an increased Marker Registration Error
Device software or design Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures. reason.device_software_design · v1.0.0 software bug
Device software or design Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. reason.device_software_design · v1.0.0 software issue

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