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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 1577 of 1581

Evidence Product Join Root cause
device-recall:cfres:122661 Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region. Official recall number · Z-0802-2014 Device Design
device-recall:cfres:124676 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. The Solar 8000i with Patient Data Module/Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctors office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICU), pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output nad respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: Electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, CO2 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of GE Healthcare Page 3 of 6 monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, O2, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and /or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The solar 8000i patient monitoring system also provides physiological data over the Unity Network. Official recall number · Z-0807-2014 Pending
device-recall:cfres:125349 GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station. Official recall number · Z-0982-2014 Software design
device-recall:cfres:125451 Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121. Official recall number · Z-0969-2014 Device Design
device-recall:cfres:119833 MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702. Official recall number · Z-0943-2014 Process design
device-recall:cfres:125111 T:slim Insulin Delivery System Insulin Infusion Pump Official recall number · Z-0827-2014 Equipment maintenance
device-recall:cfres:125360 Horizon Medical Imaging, Picture Archive Communication System (PACS). Official recall number · Z-0976-2014 Software design
device-recall:cfres:125127 Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void Official recall number · Z-0977-2014 Packaging process control
device-recall:cfres:124519 BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy. Official recall number · Z-0967-2014 Nonconforming Material/Component
device-recall:cfres:211119 Fusion Pro 24, Model 17000 Official recall number · Z-0524-2025 Radiation Control for Health and Safety Act
device-recall:cfres:209544 Pump 371 14F LT CMR Set; Product Code: 0048-0045; Official recall number · Z-2959-2024 Under Investigation by firm
device-recall:cfres:209553 Impella 5.5 Set AU; Product Code: 1000361; Official recall number · Z-2968-2024 Under Investigation by firm
device-recall:cfres:209543 Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; Official recall number · Z-2958-2024 Under Investigation by firm
device-recall:cfres:209557 Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; Official recall number · Z-2971-2024 Under Investigation by firm
device-recall:cfres:214062 Lazervida 10W diode laser cutter and engraver with Lazervida shield. Official recall number · Z-1878-2025 Unavailable
device-recall:cfres:210298 SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS). Official recall number · Z-1073-2025 Device Design
device-recall:cfres:207500 RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator. Official recall number · Z-1933-2024 Software design
device-recall:cfres:204925 FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit) Official recall number · Z-0994-2024 Under Investigation by firm
device-recall:cfres:181773 COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176 Official recall number · Z-2498-2020 Labeling design
device-recall:cfres:195967 Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007 Official recall number · Z-1774-2022 Employee error
device-recall:cfres:196320 Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830 Official recall number · Z-0168-2023 Device Design
device-recall:cfres:172735 CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia Official recall number · Z-1773-2019 Process control
device-recall:cfres:162017 radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Official recall number · Z-2725-2018 Under Investigation by firm
device-recall:cfres:162006 #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Official recall number · Z-2716-2018 Under Investigation by firm
device-recall:cfres:162015 radial head implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. Official recall number · Z-2723-2018 Under Investigation by firm