CellaVision DM Software versions 6 — Class II medical device recall Z-2184-2018
Ongoing recall by Cellavision AB, reported 2018-06-20, distributed nationwide. A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent t
| Recall number | Z-2184-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cellavision AB, Lund, N/A, Sweden |
| Recall initiated | 2017-12-04 |
| Classified | 2018-06-13 |
| Reported by FDA | 2018-06-20 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction, software |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2184-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.