iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Reported: May 6, 2020 Initiated: September 18, 2019 #Z-1804-2020
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 150 units
- Distribution
- OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System. Recalled by Boston Scientific Corporation. Units affected: 150 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1804-2020.
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