Recall Z-2039-2016 ยท JOY Device, Automated Cell-Locating
Leica Biosystems Richmond Inc.
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.
| Date | May 2, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Leica Biosystems Richmond sent Medical device Field Correction notification letters to the customers of the potentially affected product. The initial written communication was sent to the customers via first class USPS on May 2, 2016. According to the firm a decision to conduct a Field Corrective Actions of the Ariol Image Analysis and Scanning Systems was done out of an abundance of caution. The Medical Device Field Correction letter describes the issues identified with the CytoVision Image Analysis and Capture System and the Windows 7 operating system. The letter provided the customer with a |
| Quantity | 283 systems |
| Distribution | Worldwide distribution. US nationwide; Portugal, Spain, Thailand, Italy, China, Romania, Egypt, India, France, Hungary, Mexico, Germany, Norway, Turkey, Pakistan, Malaysia, UK, Luxembourg, Israel, Canada, Switzerland, Taiwan, South Africa, Saudi Arabia, Korea, Singapore and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042542 | CYTOVISION FOR CEP XY Applied Imaging Corp., Jan 10, 2005 |