Events

Rappel de Thermo Scientific Microm

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Richard-Allan Scientific Company.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    59316
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0039-2012
  • Date de mise en oeuvre de l'événement
    2011-08-12
  • Date de publication de l'événement
    2011-10-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102246
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Microtome, Rotary - Product Code IDO
  • Cause
    The firm has received two complaints of finger lacerations in operators of this device.
  • Action
    ThermoFisher Scientific sent "URGENT MEDICAL DEVICE CORRECTION, RE: Thermo Scientific HM355S-3 User Safety Advisory Notice" to all affected customers. The letter states the manufacturer identified a need to enhance the safety instructions and the description of the safety devices in the user manual. It mentions the HM3555S-3 User Manual has been modified to include more specific safe work practices and a new Quick -Reference Card summarizing the manual's safety enhancements and that the changes have been included on a CD that is enclosed with the letter. The firm requests confirmation of receipt of the new User Manual and Quick-Reference Card by October 31, 2011 to be sent by FAX to (269) 372-2674 For questions on this recall call the firms Technical Support representatives at 1-800-522-7270 08:00 AM- 4:30 PM.

Device

Thermo Scientific Microm
  • Modèle / numéro de série
    Model HM355S-3, Serial Nos: 34450, 34519, 34520, 34601, 34662, 34665, 34807, 34922, 35030, 35032, 35033, 35159, 35637, 35793, 35976, 35978, 35978, 38337, 38584, 38651, 39238, 39280, 39281, 39542, 39795, 40607, 41039, 45104, 45367, 45369, 45371, 45760, 45845, 47466, 47467, 47468, 47469, 47772, 47773, 47774, 47775, 47776, 48095, 48096, 48097, 48098, 48109, 48110, 48111, 48112, 48113, 48114, 48115, 48116, 48184, 48252, 48253, 48254, 48259, 48260, 48261, 48314, 48315, 48593, 48594, 48910, 48911, 48912, 48913, 48914, 48915, 48916, 48917, 48918, 48919, 48920, 48921, 48922, 48923, 48924, 48978, 48978, 49102, 49103, 49104, 49105, 49106, 49107, 49108, 49109, 49110, 49209, 49209, 49210, 49210, 49211, 49211, 49212, 49213, 49213, 49214, 49214, 49221, 49223, 49230, 49286, 49287, 49288, 49289, 49290, 49291, 49292, 49293, 49294, 49295, 49296, 49297, 49298, 49299, 49300, 49301, 49302, 49303, 49304, 49305, 49306, 49307, 49308, 49309, 49310, 49311, 49312, 49962, 49963, 49964, 49965, 49966, 49967, 49968, 49969, 49970, 49971, 49972, 49973, 49974, 49975, 49976, 49977, 49978, 49989, 49990, 49991, 49992, 49993, 49994, 49995, 50221, 50222, 50224, 50225, 50226, 50578, 50579, 50580, 50581, 50582, 50583, 50584, 50585, 50586, 50587, 50676, 50677, 50678, 50679, 50680, 50681, 50791, 50792, 50793, 50794 and 50911.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: Nationwide distribution; including the country of Canada.
  • Description du dispositif
    Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 || Used for slicing tissue blocks.
  • Manufacturer
    Richard-Allan Scientific Company

Manufacturer

Richard-Allan Scientific Company
  • Adresse du fabricant
    Richard-Allan Scientific Company, 4481 Campus Dr, Kalamazoo MI 49008
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA