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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1507 of 1581

Evidence Product Join Root cause
device-recall:cfres:162989 Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. Official recall number · Z-1586-2018 Software design
device-recall:cfres:162963 Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system 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. Official recall number · Z-1411-2018 Software design
device-recall:cfres:163127 GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. Official recall number · Z-1393-2018 Software design
device-recall:cfres:162847 Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system. Official recall number · Z-1478-2018 Employee error
device-recall:cfres:162855 Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers. Official recall number · Z-1389-2018 Nonconforming Material/Component
device-recall:cfres:163129 GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. Official recall number · Z-1395-2018 Software design
device-recall:cfres:162726 T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. Official recall number · Z-1438-2018 Nonconforming Material/Component
device-recall:cfres:162959 Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system 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. Official recall number · Z-1407-2018 Software design
device-recall:cfres:162882 Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector. Official recall number · Z-1379-2018 Software design
device-recall:cfres:162928 Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time. Official recall number · Z-1382-2018 Software Manufacturing/Software Deployment
device-recall:cfres:163344 ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Official recall number · Z-1401-2018 Software design
device-recall:cfres:162906 SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Official recall number · Z-1386-2018 Process control
device-recall:cfres:162973 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01 Official recall number · Z-1468-2018 Under Investigation by firm
device-recall:cfres:161023 Brilliance iCT - Model 728306 Computed Tomography X-ray systems Official recall number · Z-0403-2018 Software design
device-recall:cfres:160537 PROPONENT SR Pacemaker Official recall number · Z-0373-2018 Device Design
device-recall:cfres:160729 Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. Official recall number · Z-0388-2018 Under Investigation by firm
device-recall:cfres:157839 Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. Official recall number · Z-0313-2018 Component design/selection
device-recall:cfres:159896 UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. Official recall number · Z-0310-2018 Device Design
device-recall:cfres:160979 Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood. Official recall number · Z-0534-2018 Material/Component Contamination
device-recall:cfres:160796 Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle. Official recall number · Z-0576-2018 Material/Component Contamination
device-recall:cfres:161320 JS Series SterilContainer S2 System Official recall number · Z-0624-2018 No Marketing Application
device-recall:cfres:161228 Norian Drillable Inject Official recall number · Z-0617-2018 Process control
device-recall:cfres:160940 ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons. Official recall number · Z-0639-2018 Software design
device-recall:cfres:160239 Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens. Official recall number · Z-0606-2018 Mixed-up of materials/components
device-recall:cfres:158599 Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool Official recall number · Z-0603-2018 Nonconforming Material/Component

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