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.
데이터 추가 비고
Device, automated cell-locating - Product Code JOY
원인
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.
조치
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)
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