iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Reported: April 30, 2014 Initiated: April 3, 2014 #Z-1487-2014
Product Description
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Reason for Recall
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 9 units
- Distribution
- USA Nationwide Distribution in the states of NY, NC, DC, FL, PA
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.. Recalled by Boston Scientific Corporation. Units affected: 9 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2014. Severity: Moderate. Recall number: Z-1487-2014.
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