Recall Z-2184-2018 ยท JOY Device, Automated Cell-Locating
Cellavision AB
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
| Date | Dec 4, 2017 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| 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) |
| Quantity | Instruments: 224 Software: 99 (US) |
| Distribution | US Nationwide in the states of FL, IL, NY, and NC |
| FDA record | Open on fda.gov |