Events

Alerte De Sécurité sur Precision 500D, Legacy, RFX, and SFX X-ray imaging systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par GE 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
  • Date
    2013-10-02
  • Date de publication de l'événement
    2013-10-02
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002a.html
  • 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
  • Cause
    Medical device safety alert: ge healthcare precision 500d, legacy, rfx, and sfx x-ray imaging systems the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning precision 500d, legacy, rfx, and sfx x-ray imaging systems, manufactured by ge healthcare. the affected part numbers are 2258627, 2305472, 2305495, 2404103, 2403791, 2403791-3, 2403791-32, 2403791-40, 46-262751g2, 46-262751g4, 46-262751g5, 46-262751g6, 46-262751g7, and 46-262751g8. there is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. this issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the on position, and causing the system to strike the patient. no injuries have been reported to date related to this issue. the manufacturer advises users to inspect power assist handle for either of the two conditions listed below, and immediately contact local ge healthcare service representative if any issue is found. if users observe that the power assist handle plastic grip is loose relative to the mount, discontinue use. if plastic grip is secure, but users observe erratic performance, (power assist unresponsive, drifting of spotfilm device with no command, or lock release always on), users may continue to use the device with care. use all safety precautions relative to application of the myelographic stop and the inhibit, table horizontal stop off. furthermore, ge healthcare will correct all affected systems. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con316301 if you are in possession of the product, please contact your supplier for necessary actions. posted on 2 october 2013.

Device

Precision 500D, Legacy, RFX, and SFX X-ray imaging systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare Precision 500D, Legacy, RFX, and SFX X-ray imaging systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare