CytoVision Image Analysis and Capture System — Class III medical device recall Z-2039-2016
Terminated recall by Leica Biosystems Richmond Inc., reported 2016-06-29, distributed nationwide. Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with e
| Recall number | Z-2039-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Biosystems Richmond Inc., Richmond, IL, United States |
| Recall initiated | 2016-05-02 |
| Classified | 2016-06-20 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2017-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, CN, DE, EG, ES, FR, GB, HU, IL, IN, IT, JP, KR, LU, MX, MY, NO, PK, PT, RO, SA, SG, TH, TR, TW, ZA |
| Quantity | 283 systems |
| Serial numbers | 108457, 108498, 108502, 200423, 200693, 200700, 200701, 200702, 200703, 200704, 200705, 200706, 200707, 200708, 200709, 200710, 200711, 200712, 200713, 200714, 200715, 200716, 200717, 200718, 200719 and 261 more |
Product
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
Reason for recall
Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.
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-2039-2016. 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.