Events

Recall of Thermo Scientific Microm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Richard-Allan Scientific Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59316
  • Event Risk Class
    Class 2
  • Event Number
    Z-0039-2012
  • Event Initiated Date
    2011-08-12
  • Event Date Posted
    2011-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102246
  • Notes / Alerts
    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.
  • Extra notes in the data
    Microtome, Rotary - Product Code IDO
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide distribution; including the country of Canada.
  • Product Description
    Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 || Used for slicing tissue blocks.
  • Manufacturer
    Richard-Allan Scientific Company

Manufacturer

Richard-Allan Scientific Company
  • Manufacturer Address
    Richard-Allan Scientific Company, 4481 Campus Dr, Kalamazoo MI 49008
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA