donderdag 11 april 2019

IGJ waarschuwingen: Medtronic FA861 - A610 DBS Clinician Programmer Application

Medtronic FA861 - A610 DBS Clinician Programmer Application
This letter is to inform you of a potential issue with the Medtronic's A610 Deep Brain Stimulation (DBS) Clinician Programmer Application. This application runs on the Medtronic CT900 Clinician Tablet and is intended for use by clinicians to program Medtronic neurostimulators for Deep Brain Stimulation.
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Zimmer Biomet ZFA 2018-00611 - Foot and Ankle Instruments
Zimmer Biomet received a certain number of complaints reporting tip breakages. An investigation identifies that Normed Medizin Technik GmbH possibly manufactured certain lots from a different material than defined in the applicable specifications. As a precautionary measure Zimmer Biomet has decided to remove the complete family of instruments that were manufactured by Normed Medizin Technik GmbH...
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GE Healthcare FMI 40885 - Detector Mounting Screws for Nuclear Medicine Systems
Tijdens de installatie van bepaalde nucleaire geneeskundige systemen die geleverd worden met gedemonteerde detectors, kan het zijn dat sommige detectorschroeven niet goed zijn vastgedraaid, wat leidt tot het mogelijke verlies van één ontwerpredundantie van de detectorbevestiging.
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GE Healthcare FMI 60952 - AIR Anterior Array
De buitenste naad van de spoel, het dichtst bij de systeemkabel, kan loslaten en het poreuze materiaal binnenin de spoel blootleggen. Dit kan tot gevolg hebben dat de gebruiker en/of patiënt in aanraking komt met infectueuze stoffen, omdat het interne poreuze materiaal niet gedesinfecteerd kan worden.
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Intuitive Surgical ISIFA2018-21-R - da Vinci Harmonic ACE Insert
The purpose of this communication is to advise you that Intuitive Surgical is initiating a voluntary STOP USE on the da Vinci Harmonic ACE insert for use with da Vinci S and Si Surgical Systems. Intuitive Surgical identified that the sterile package for the insert can become damaged during transit.
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