Food, drugs, devices › Leica Biosystems Richmond Inc.
Device recall: CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase fin
FDA enforcement event 74245 is a device recall by Leica Biosystems Richmond Inc. of Richmond, IL, initiated 2 May 2016 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 13 Dec 2017. Initiation: voluntary: firm initiated. Leica Biosystems Richmond Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Leica Biosystems Richmond Inc., Richmond, IL.
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."
Distribution
"Worldwide distribution. US nationwide; Portugal, Spain, Thailand, Italy, China, Romania, Egypt, India, France, Hungary, Mexico, Germany, Norway, Turkey, Pakistan, Malaysia, UK, Luxembourg, Israel,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2039-2016 | 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… | 283 systems | Class III | Terminated | 29 Jun 2016 |
Context
Other enforcement events for Leica Biosystems Richmond Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Jul 2017 | Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. | Device | Class II | 7 |
| 6 May 2016 | Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an ai | Device | Class III | 1 |
All 3 events for Leica Biosystems Richmond Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US nationwide; Portugal, Spain, Thailand, Italy, China, Romania, Egypt, India, France, Hungary, Mexico, Germany, Norway, Turkey, Pakistan, Malaysia, UK, Luxembourg, Israel,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Dec 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.