Events

Recall of Device Recall CellaVision DM96, DM1200, DM9600 and DI60

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cellavision AB.

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
    80137
  • Event Risk Class
    Class 2
  • Event Number
    Z-2184-2018
  • Event Initiated Date
    2017-12-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164663
  • 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
    Device, automated cell-locating - Product Code JOY
  • Reason
    A software malfunction was found where wbc, rbc and plt comments added after a slide is signed, are not sent to the lis. this can only occur where customers process multiple slides per blood sample.
  • Action
    CellaVision sent an Urgent Medical Device Recall letter dated December 4, 2017. The letter identified affected product, problem and the actions to be taken. Customers are requested to determine if they are affected or not. If affected they are requested to contact their local distributor for installing a patch. Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to their local distributor. For technical questions contact CelleVision (service@cellavision.se)

Device

Device Recall CellaVision DM96, DM1200, DM9600 and DI60
  • Model / Serial
    Versions 6.0.1 or 6.0.2
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of FL, IL, NY, and NC
  • Product Description
    CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 || Product Usage: || The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
  • Manufacturer
    Cellavision AB

Manufacturer

Cellavision AB
  • Manufacturer Address
    Cellavision AB, Forskningsbyn Ideon, Scheelevagen 19a, Lund Sweden
  • Manufacturer Parent Company (2017)
    CellaVision AB
  • Source
    USFDA