Device product
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
Z-2184-2018
Product summary
- Firm
- Cellavision AB
- Event
- Event 80137
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Instruments: 224 Software: 99 (US)
- Official record key
device-enforcement:Z-2184-2018
Official wording
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.
Code information: Versions 6.0.1 or 6.0.2
Distribution pattern: US Nationwide in the states of FL, IL, NY, and NC
Derived failure modes
-
Device software or design
software malfunction