510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1693-2008

iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation...

Boston Scientific Corporation / initiated 2000-04-11 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Boston Scientific Corporation began a recall of iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538 on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1693-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Boston Scientific Corporation
Product
iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
Root cause tag
manufacturing process
FDA root 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.
Product codes and lots
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.