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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 24 of 3592

Mode Product Rule Evidence excerpt
Device software or design cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate. reason.device_software_design · v1.0.0 software responsible for starting scheduled AutoQC measurements (scheduler) will
Device software or design Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130 reason.device_software_design · v1.0.0 Software issue with Center Beam in Field functionality. Issue
Device software or design Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body. reason.device_software_design · v1.0.0 anomaly was identified with software
Device software or design Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures. reason.device_software_design · v1.0.0 programming error
Device software or design VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest. reason.device_software_design · v1.0.0 Software Anomaly
Device software or design NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis. reason.device_software_design · v1.0.0 software error
Device software or design da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue. The instrument tip is blunt and intended to contact tissue. reason.device_software_design · v1.0.0 software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can
Device software or design DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets. reason.device_software_design · v1.0.0 software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes
Device software or design Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. reason.device_software_design · v1.0.0 Software issues including: Software errors that may result in
Device software or design VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. reason.device_software_design · v1.0.0 error by prior to FDA approval of version 1.0.2.2 software
Device software or design cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate. reason.device_software_design · v1.0.0 software responsible for starting scheduled AutoQC measurements (scheduler) will
Device software or design Artis zee, Angiographic x-ray system reason.device_software_design · v1.0.0 Software error - As a result of a software fault
Device software or design Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design OTTO BOCK Kenevo knee joints Model 3C60 reason.device_software_design · v1.0.0 design issue
Device software or design VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H reason.device_software_design · v1.0.0 design verification test failures
Device software or design Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, and white-to-white distance. The Pentacam AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation. reason.device_software_design · v1.0.0 software versions have an anomaly
Device software or design Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors. reason.device_software_design · v1.0.0 software anomaly
Device software or design Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. reason.device_software_design · v1.0.0 software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may
Device software or design Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles.SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. reason.device_software_design · v1.0.0 software version VB20A may
Device software or design Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001 reason.device_software_design · v1.0.0 software failure
Device software or design Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX. reason.device_software_design · v1.0.0 design incompatibility
Device software or design Syngo.via systems with SW VB20A reason.device_software_design · v1.0.0 software installation and upgrading syngo.via system to the software version VB20A_HF02 will

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