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Implants & Prosthetics

🏥 Medical Devices • 4,589 recalls

Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus lift, and implant preparation.

Nakanishi

Class I - Dangerous

Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.

Jul 8, 2016 Implants & Prosthetics Nationwide View Details →

Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.

Alcon Research

Class I - Dangerous

The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System

Jul 28, 2016 Implants & Prosthetics View Details →

NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer. The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a computer monitor or portable device. NovaPACS tools/features include the following: window, level, zoom, pan, digital subtraction, ejection fraction, cross localization, note-taking ability, voice dictation, and other similar tools. It includes the capability to measure distance and image intensity values, such as standardized uptake value. NovaPACS displays measurement lines, annotations, regions of interest, and fusion blending control functionality. Advanced features include 3D image rendering, virtual colonoscopy, and vessel analysis. Images and data are stored on a digital archive with multiple redundancies; images and data are available on-site and offsite. Novarad provides all software, including third party software (i.e. Windows¿ OS). NovaPACS software resides on third party hardware, which may vary depending on the client s PACS needs. All hardware is connected to the radiology department local area network. NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities. NovaPACS is intended for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc. NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images. NovaPACS is not intended for diagnostic image review on a mobile platform. While NovaPACS provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application

Novarad

Class I - Dangerous

Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released.

Aug 12, 2016 Implants & Prosthetics Nationwide View Details →

Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patients heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies.

Medtronic Inc., Cardiac Rhythm and Heart Failure

Class I - Dangerous

78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.

Aug 12, 2016 Implants & Prosthetics Nationwide View Details →

DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.

Medtronic Neuromodulation

Class I - Dangerous

Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.

Jun 23, 2016 Implants & Prosthetics View Details →

Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardioverter defibrillator (lCD) are a family of multiprogrammable cardiac devices that monitor and regulate the patients heart rate by providing dual or single chamber rate-responsive bradycardia pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies (dual-chamber devices only).

Medtronic Inc., Cardiac Rhythm and Heart Failure

Class I - Dangerous

78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.

Aug 12, 2016 Implants & Prosthetics Nationwide View Details →
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