Events

Alerte De Sécurité sur cobas c 501 module and cobas c 502

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Roche Diagnostics.

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
    2017-07-20
  • Date de publication de l'événement
    2017-07-20
  • 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_20170720.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: roche diagnostics cobas c 501 module and cobas c 502 module medical device manufacturer, roche diagnostics, has issued a medical device safety alert concerning its ultrasonic mixer cover (usm cover 3) [catalogue number: 05400937001]. the affected systems are cobas c 501 module [catalogue number: 04745914001] and cobas c 502 module [catalogue number: 05964067001]. the manufacturer informed users that an operator was injured during a maintenance task, when removing the ultrasonic mixer cover (usm cover 3) of a cobas c 502 module. considering that cobas c 501 and cobas c 502 modules share the same hardware, the manufacturer decided to inform and request operators of both systems to perform the related maintenance task with special caution, so as to prevent further occurrence of the issue. when the operator cleans the incubation bath or replaces cuvettes on cobas c 501 and cobas c 502 modules, during monthly maintenance, the usm cover 3 has to be removed and its two thumb screws have to be loosened. according to the manufacturer, the affected product was launched in 2006, this was the only one incident has been reported. the manufacturer advises customers not to overtighten the thumb screws when replacing the cover after maintenance. when removing the screws for maintenance avoid touching the edge of the usm cover 3. a warning will be added to the respective operator manuals:- the cobas c 501 module is bound to the cobas 6000 analyzer series operator’s manual. the cobas c 502 module is bound to the cobas 8000 modular analyzer series operator’s manual. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 july 2017.

Device

cobas c 501 module and cobas c 502
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche Diagnostics cobas c 501 module and cobas c 502 module
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics