Class 2 Device Recall iLab Ultrasound Imaging System

• Date Initiated by Firm: April 11, 2000
• Date Posted: September 23, 2008
• Recall Status: Terminated on April 06, 2009
• Recall Number: Z-1693-2008
• Recall Event ID: 47759
• 510(K)Number: K072517
• Product Classification: Ultrasound imaging system - Product Code IYO
• Product: iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538
• Code Information: UPNs: H74900036130, H749FG000940, H749ILAB120INS0, H749ILAB120INSR0, H749ILAB220INS0, H749240INS0, M004EPIL120INS0. Serial numbers 0000004082, 0000004385, 0000004386, 0000004387, 0000004388, 0000004389, 0000004390, 0000004391, 0000004392, 0000004393, 0000004396, 0000004397, 0000004398, 0000004399, 0000004416, 0000004417, 0000004418, 0000004419, 0000004420, 0000004421, 0000004422, 0000004423, 0000004424, 0000004425, 0000004426, 0000004427, 0000004428, 0000004429, 0000004430, 0000004431, 0000004432, 0000004433, 0000004434, 0000004435, 0000004436, 0000004439, 0000004441, 0000004442, 0000004443, 0000004444, 0000004445, 0000004446, 0000004447, 0000004448, 0000004453, 0000004454, 0000004455, 0000004456, 0000004468, 0000004469, 0000004472, 0000004473, 0000004480, 0000004487, 0000004488, 0000004489, 0000004490, 0000004491, 0000004494, 0000004495, 0000004496, 0000004497, 0000004498, 0000004505, 0000004506, 0000004507, 0000004512, 0000004513, 0000004514, 0000004515, 0000004516, 0000004520, 0000004521, 0000004522, 0000004523, 0000004524, 0000004525, 0000004526, 0000004529, 0000004538, 0000004539, 0000004548, 0000004549, 0000004550, 0000004551, 0000004556, 0000004557, 0000004558, 0000004559, 0000004564, 0000004565, 0000004566, 0000004567, 0000004572, 0000004573, 0000004574, 0000004575, 0000004580, 0000004581, 0000004582, 0000004583, 0000004584, 0000004585, 0000004586, 0000004587, 0000004610, 0000004702, 0000004703, 0000004704, 0000004705, 0000004717, 0000004718, 0000004719, 0000004720, 0000004726, 0000004728, 0000004729, 0000004730, 0000004731, 0000004732, 0000004737, 0000004738, 0000004751, 0000035228, 0000035229, 0000035390, 0000035391, 0000036314, 0000094718, 0009430893, 0009503458, 0009543381, 0009565345, 0009902558, 0009602559, 0009626567, 0009640091, 0009828054, 0009828055, 0009828344, 0011008866.
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 47900 Bayside Pkwy; Fremont CA 94538-6515
• For Additional Information Contact: 508-652-5594
• Manufacturer Reason for Recall: Improperly terminated wires on a component of the iLab Acquisition processor power supply could cause the processor to lock-up or stop, and prolong the patients procedure.
• FDA Determined Cause: Process control
• Action: On April 4 and 10, 2008, customer notifcations were sent to consignees. Field corrections are estimated to begin on April 25, 2008.
• Quantity in Commerce: 120 units
• Distribution: Product was distributed to a total of 81 consignees in the USA, Hong Kong, Great Britain, Austria and France.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYO