Boston Scientific Corporation - iLab Ultrasound Imaging System - Class 2 Recall

iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Product Usage: The iLab Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy. Automatic Pullback is indicated for the following use cases: The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator. The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed. Two-dimensional, longitudinal reconstruction of the anatomy is desired.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts