Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1487-2014 — iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.

U.S. FDA — Device Enforcement · United States · 2014-04-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1487-2014
Date of alert
2014-04-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Reported risk: Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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