FDA-Device2020-05-06Class II
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Hazard
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.
Sold states
OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees.
Affected count
150 units
Manufactured in
300 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1804-2020More Boston Scientific Corporation recalls
- FDA-Device2026-07-22Boston Scientific Rapid Refill Continuous Injection System recalled for syringe disconnection risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for sterile pouch breach risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief