Skip to content
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 14 of 3592

Mode Product Rule Evidence excerpt
Device software or design The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software reason.device_software_design · v1.0.0 Software issues that may cause
Device software or design Solero Generator PG, Item No. H78712740000, Catalog No. 12740000 reason.device_software_design · v1.0.0 software to help reduce the incidence of Error
Device software or design Software versions syngo.CT VB20 or VB20_SP1 in the following systems: 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) SOMATOM Edge Plus (Model #10267000) reason.device_software_design · v1.0.0 software may result in scanning workflow interruptions
Device software or design Revolution EVO, Optima CT660, Optima CT680 CT Systems. reason.device_software_design · v1.0.0 software options may result in
Device software or design Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010 Rev B 453564483321 Flex Cardio FC2010 Rev C 453564621791 Xper Flex Cardio 2010 REV C RUEXCHANGE 453564675021 Xper Flex Cardio 2010 Rev D 453564669081 Xper Flex Cardio 2010 Rev D Russia 453564674581 Xper Flex Cardio FC2010 Rev E 453564845841 Xper Flex Cardio 2010 Rev E Russia 453564845881 Service numbers associated with FC2020: Xper Flex Cardio 2020 Rev A 453564241911 Xper Flex Cardio 2020 Rev B 453564483331 Flex Cardio FC2020 Rev C 453564621801 Xper Flex Cardio 2020 Rev D 453564675001 Xper Flex Cardio FC2020 Rev E 453564845861 Software version number: 1.5.19 and 1.6.8 reason.device_software_design · v1.0.0 software used with the Xper Flex Cardio Physio Monitoring System may
Device software or design syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 reason.device_software_design · v1.0.0 software does not recognize the adapted acquisition plane. This may result in
Device software or design 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal reason.device_software_design · v1.0.0 software issue
Device software or design Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only reason.device_software_design · v1.0.0 firmware issue
Device software or design Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. reason.device_software_design · v1.0.0 software defect
Device software or design All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 100-240V 50/60 Hz, 600 VA MOD - Affinity 30 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 50 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 70 GMDN - 40761 100-240V 50/60 Hz, 450 VA reason.device_software_design · v1.0.0 issue(s) manifest differently for different versions of software
Device software or design Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head. reason.device_software_design · v1.0.0 software problem
Device software or design MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS). reason.device_software_design · v1.0.0 software malfunction
Device software or design POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide. reason.device_software_design · v1.0.0 design issue
Device software or design RayStation 8A Service Pack 1, UDI # 07350002010136 - 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 Aptio 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) - Product Usage: 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 MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions. reason.device_software_design · v1.0.0 software malfunction
Device software or design Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: 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 da Vinci SP surgical system reason.device_software_design · v1.0.0 software anomaly. This issue
Device software or design MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection. reason.device_software_design · v1.0.0 software malfunction
Device software or design RayStation 7, UDI # 07350002010068 - 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 Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures. reason.device_software_design · v1.0.0 software for the celling arm of the X-Ray System . This software issue
Device software or design Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - 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 version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may
Device software or design RayStation 5 Service Pack 3, UDI # 07350002010020 - 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 CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870 reason.device_software_design · v1.0.0 Software defect
Device software or design RayStation 4.0 to RayStation 5 Service Pack 2 - 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

Field note

Send feedback

We'll only use this to respond to your feedback.