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
- Recall Initiated
- December 4, 2017
- Recall Number
- Z-2184-2018
- Quantity
- Instruments: 224 Software: 99 (US)
Reason for Recall
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.
Distribution
US Nationwide in the states of FL, IL, NY, and NC
Lot / Code Info
Versions 6.0.1 or 6.0.2
Root Cause
Software design
Action Taken
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)