CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision ...
FDA Device Recall #Z-2184-2018 — Class II — December 4, 2017
Recall Summary
| Recall Number | Z-2184-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 4, 2017 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cellavision AB |
| Location | Lund, N/A |
| Product Type | Devices |
| Quantity | Instruments: 224 Software: 99 (US) |
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
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 Pattern
US Nationwide in the states of FL, IL, NY, and NC
Lot / Code Information
Versions 6.0.1 or 6.0.2
Other Recalls from Cellavision AB
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0542-2026 | Class II | REF: CC286297 or BS737162 Automated Digital Ce... | Oct 8, 2025 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.