—#70087

Product

iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538

FDA product code: IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072517
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

On April 4 and 10, 2008, customer notifcations were sent to consignees. Field corrections are estimated to begin on April 25, 2008.

Recalling firm

Firm: Boston Scientific Corporation
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: Product was distributed to a total of 81 consignees in the USA, Hong Kong, Great Britain, Austria and France.

Timeline

Recall initiated: 2000-04-11
Posted by FDA: 2008-09-23
Terminated: 2009-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70087. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.