Events

Recall of iLab Ultrasound Imaging System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    47759
  • Event Risk Class
    Class 2
  • Event Number
    Z-1693-2008
  • Event Initiated Date
    2000-04-11
  • Event Date Posted
    2008-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70087
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ultrasound imaging system - Product Code IYO
  • Reason
    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.
  • Action
    On April 4 and 10, 2008, customer notifcations were sent to consignees. Field corrections are estimated to begin on April 25, 2008.

Device

iLab Ultrasound Imaging System
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to a total of 81 consignees in the USA, Hong Kong, Great Britain, Austria and France.
  • Product Description
    iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA