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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 1562 of 1581

Evidence Product Join Root cause
device-recall:cfres:121557 GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 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 healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. Official recall number · Z-2256-2013 Software design
device-recall:cfres:121334 OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor Official recall number · Z-2224-2013 Packaging
device-recall:cfres:121335 OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor Official recall number · Z-2225-2013 Packaging
device-recall:cfres:121580 Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer. Official recall number · Z-2209-2013 Labeling Change Control
device-recall:cfres:120170 Artis zee systems x-ray, angiographic system Official recall number · Z-0172-2014 Device Design
device-recall:cfres:122021 Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Official recall number · Z-0256-2014 Software design
device-recall:cfres:122198 VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Official recall number · Z-0321-2014 Equipment maintenance
device-recall:cfres:122150 VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Official recall number · Z-0298-2014 Equipment maintenance
device-recall:cfres:121986 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Official recall number · Z-0224-2014 Software design
device-recall:cfres:122201 VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Official recall number · Z-0324-2014 Equipment maintenance
device-recall:cfres:122514 Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Official recall number · Z-0279-2014 Software design
device-recall:cfres:122561 Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care Official recall number · Z-0282-2014 Equipment maintenance
device-recall:cfres:122583 The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Official recall number · Z-0286-2014 Component design/selection
device-recall:cfres:115366 Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Official recall number · Z-0203-2014 Nonconforming Material/Component
device-recall:cfres:120535 Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone. Official recall number · Z-0198-2014 Labeling Change Control
device-recall:cfres:120360 Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement. Official recall number · Z-1981-2013 Packaging process control
device-recall:cfres:119576 Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps. Official recall number · Z-1745-2013 Device Design
device-recall:cfres:121296 Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. Official recall number · Z-2158-2013 Packaging process control
device-recall:cfres:117466 CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Official recall number · Z-2134-2013 Process control
device-recall:cfres:121128 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Official recall number · Z-2183-2013 Process control
device-recall:cfres:121388 Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels &#38; MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Official recall number · Z-2119-2013 Process control
device-recall:cfres:121495 AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic. Official recall number · Z-2195-2013 Device Design
device-recall:cfres:121286 Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures Official recall number · Z-2160-2013 Radiation Control for Health and Safety Act
device-recall:cfres:121417 Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels &#38; MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Official recall number · Z-2126-2013 Process control
device-recall:cfres:121419 Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels &#38; MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Official recall number · Z-2128-2013 Process control

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