FDA Device recall Z-2039-2016
CytoVision Image Analysis and Capture System, an automated cell-locating device
- FDA Device
- Class III
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class III recall of CytoVision Image Analysis and Capture System, an automated cell-locating device by Leica Biosystems Richmond, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2039-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-02 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Leica Biosystems Richmond |
| Distribution | US |
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
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.
Identifiers
| code_info | System 23CAP001KXX001 with Serial Number 201021, System 23CAP001KXX001 with Serial Number 201020, System 23CAP001KXX001…System 23CAP001KXX001 with Serial Number 201021, System 23CAP001KXX001 with Serial Number 201020, System 23CAP001KXX001 with Serial Number 200994, System 23CAP001KFX001 with Serial Number 200752, System 23GSLXXXKFXUPG with Serial Number 201013, System 23GSLXXXKFXUPG with Serial Number 201050, System 23CAP007FXX001 with Serial Number 200930, System 23CAP002KFX001 with Serial Number 201000, System 23CAP001KXX001 with Serial Number 200969, System 23CAP001KFX001 with Serial Number 200942, System 23GSL120KFX001 with Serial Number 200910, System 23CAP001FXX001 with Serial Number 200710, System 23GSLXXXKFXUPG with Serial Number 200890, System 23GSL120KFX001 with Serial Number 201001System 23CAP002FXX001 with Serial Number 200889, System 23GSLXXXKFXUPG with Serial Number 201087, System 23CUP003CVX720 with Serial Number 201086, System 23GSL10XKXX001 with Serial Number 201085, System 23REV001XXX001 with Serial Number 201084, System 23REV001XXX001 with Serial Number 201083, Sy |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2039-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.