Recall Z-1804-2020— Boston Scientific Corporation
Class II · Completed
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2019-09-18. It names one FDA 510(k) clearance: K191008. Product: iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System. 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Completed
- Initiated
- 2019-09-18
- Firm location
- Marlborough, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.