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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 16 of 3592

Mode Product Rule Evidence excerpt
Device software or design Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: 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 TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18 reason.device_software_design · v1.0.0 software issue
Device software or design CareFusion Alaris Syringe Module, Model 8110 reason.device_software_design · v1.0.0 Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in
Device software or design Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region of the electromagnetic spectrum. The UV radiation falls within the range of ultraviolet B (UVB), which is used to treat photo-responsive skin disorders. reason.device_software_design · v1.0.0 software error
Device software or design Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. reason.device_software_design · v1.0.0 software may
Device software or design MiniMed Insulin Pump, model # MMT-508 reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design CareFusion Alaris Pump Module, Model 8100 reason.device_software_design · v1.0.0 Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in
Device software or design Medtronic MiniMed Paradigm Insulin pump, model number MMT-723 reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. reason.device_software_design · v1.0.0 Software error
Device software or design FlexLab 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 CareFusion Alaris PCA Module, Model 8120 reason.device_software_design · v1.0.0 Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in
Device software or design CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) reason.device_software_design · v1.0.0 Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in
Device software or design In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-HP, FT8MIH-W-HP, FT8MIH-W-MP, LT5CIC-MP, LT5CIC-UP, LT5IIC-LP, LT5ITC-DW-MP, LT5ITC-DW-UP, LT5ITE-DW-HP, LT5ITE-DW-MP, LT5ITE-DW-UP, LT5MIH-W-HP, LT5MIH-W-MP, LT5MIH-W-UP, LT7CIC-HP, LT7CIC-LP, LT7CIC-MP, LT7CIC-W-MP, LT7IIC-LP, LT7ITC-DW-LP, LT7ITC-DW-MP, LT7ITC-MP, LT7ITC-W-HP, LT7ITC-W-MP, LT7ITE-DW-HP, LT7ITE-DW-MP, LT7ITE-DW-UP, LT7ITE-W-UP, LT7MIH-W-HP, LT7MIH-W-LP, LT7MIH-W-MP, LT9CIC-HP, LT9CIC-MP, LT9CIC-W-MP, LT9IIC-LP, LT9ITC-DW-HP, LT9ITC-DW-LP, LT9ITC-DW-MP, LT9ITE-DW-HP, LT9ITE-DW-MP, LT9ITE-DW-UP, LT9MIH-HP, LT9MIH-MP, LT9MIH-W-HP, LT9MIH-W-LP, LT9MIH-W-MP, TST17IIC-LP, TST17ITC-DW-HP, TST17ITE-HP, TST17MIH-W-UP, TST6CIC-HP, TST6IIC-LP, TST6ITC-MP, TST6ITC-W-HP, TST6ITC-W-MP, TST6ITE-DW-UP, TST6ITE-HP, TST6ITE-W-UP, TST6MIH-W-HP, TST9ITC-DW-MP, TST9ITE-DW-HP, TST9ITE-MP, TST9MIH-W-MP, VA8CIC-HP, VA8CIC-MP, VA8IIC-LP, VA8ITC-DW-HP, VA8ITC-DW-MP, VA8ITC-W-MP, VA8ITE-D-HP, VA8ITE-DW-HP, VA8ITE-DW-UP, VA8MIH-W-MP reason.device_software_design · v1.0.0 software bug
Device software or design FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation. reason.device_software_design · v1.0.0 firmware versions, in case a Clot Detection error (error
Device software or design NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0) reason.device_software_design · v1.0.0 software issue which may result in failure
Device software or design RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. reason.device_software_design · v1.0.0 Software error
Device software or design Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. reason.device_software_design · v1.0.0 Software error
Device software or design RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. reason.device_software_design · v1.0.0 Software error
Device software or design Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. reason.device_software_design · v1.0.0 software bugs in R001.3.0.0.750505 software version may cause an issue
Device software or design MiniMed Paradigm Model 511 Insulin Pump reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. reason.device_software_design · v1.0.0 Software error
Device software or design Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754 reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. reason.device_software_design · v1.0.0 Software error

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