Recall Z-1804-2020 ยท DQK Computer, Diagnostic, Programmable
Boston Scientific Corporation
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
| Date | Sep 18, 2019 |
| Status | Completed |
| Reason | Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (US) or SC Image Storage formats are used, the DFR data will not be archived and the user will not be notified of this unexpected behavior. |
| Root cause | Other |
| Action | On September 18, 2019, customers that were upgraded with version 54 of iLab Polaris 2.10 (disk batch 629774) software were sent a customer letter via overnight mail delivery. The letter provides instructions and recommendations to the user until a software upgrade (disk batch 636991) was completed. The firm informed that a firm representative will be in contact with customers directly to schedule a software upgrade at their facilities.The firm advises that systems can continue to be used during the time following the recommendations and instructions within the letter. Additionally, in the f |
| Quantity | 150 units |
| Distribution | OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191008 | iLab Polaris Multi-Modality Guidance System Boston Scientific Corporation, Jul 2, 2019 |