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Alerte De Sécurité sur brilliance 64 and ingenuity ct scanners
Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Philips Healthcare.
Qu'est-ce que c'est?
Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.
En savoir plus sur les données ici-
Type d'événement
Safety alert
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Date
2015-08-21
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Date de publication de l'événement
2015-08-21
- Pays de l'événement
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Source de l'événement
DH
- URL de la source de l'événement
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Notes / Alertes
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong. -
Notes supplémentaires dans les données
Medical Device Safety Alert
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Cause
Medical device safety alert: philips healthcare brilliance 64 and ingenuity ct scanners medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its brilliance 64 and ingenuity computed tomography (ct) scanners. the affected ct systems are brilliance 64, ingenuity ct, ingenuity core and ingenuity core128. only systems with the following versions are affected: 4.0.X.Xxxx- any version of 4.0 4.1.Y.Xxxx -only version up to and including 4.1.4. according to the manufacturer, some scans unexpectedly set the axial (z axis) scan length to a greater length than the user set in the plan. the issue occurs only when the following three conditions are met: the plan employs dual-surview the plan requests either a sagittal or a coronal reconstruction the gantry is tilted there is a potential for undesired radiation to areas not intended to be scanned. the manufacturer is not recommending users to stop using the equipment. to eliminate the possibility of the defect from occurring, users are advised to eliminate any one of the three conditions mentioned above which is needed to trigger the behaviour. the manufacturer is developing a new version of software to eliminate the defect. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 august 2015.
Device
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Modèle / numéro de série
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Description du dispositif
Medical Device Safety Alert: Philips Healthcare Brilliance 64 and Ingenuity CT Scanners
- Manufacturer
Manufacturer
- Société-mère du fabricant (2017)
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Source
DH