Events

Recall of Linvatec LS 7500, 300 Watt Xenon Light Source

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

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
    33059
  • Event Risk Class
    Class 2
  • Event Number
    Z-1531-05
  • Event Initiated Date
    2005-08-01
  • Event Date Posted
    2005-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41269
  • 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
    Light Source, Endoscope, Xenon Arc - Product Code GCT
  • Reason
    Through the complaint handling system, the company has determine there are performance issued involving the ls7500, 300 watt xenon light source. the performance issues result in a low light output that can create poor illumination of the surgical site.

Device

Linvatec LS 7500, 300 Watt Xenon Light Source
  • Model / Serial
    Lot/Serial Numbers: 43293 44784 45788 46207 46200 45794 44545 44546 44558 45809 41542 41544 44739 44810 44751 45791 46217 43316 44210 44271 44548 42025 42905 41487 40550 42914 42917 42919 44736 45850 46151 40533 45792 43271 46117 40580 40534 42878 42099 42899   46113 46243 46099 43243 45777 45855 45857 42902 46185 40572 43304 46204 45848 45852 45813 46216 45775 42891 46199 46202 46129 46143 44237 46127 40527 42885 40555 40582 44826 44777 44775 44803 44761 44802 40548 43283 40546 44262 44275 44267 44268 44785 44812 44770 44786 44788 44827 44791 44794 44778 43284 43971 43301 43973 43273 40570 42073 46209 46218 46159 46244 46240 44799 44809 42065 42054 42070 45764 44797 44783 44820 42895 42894 42892 42999 40579 42889 41560 41563 44753 42097 42106 42880 44547 41998 42017 42014 41993 44565 44570 41527 40565 42884 40568 42102 42888 46182 46164 46168 43254 41561 44549 43269 40528 42068 43312 43306 42006 43249 43238 43281 43282 44767 44764 44765 43285 43270 42069 40562 40549 44224 44220 42896 41517 41531 40560 40557 45782 40545 44218 46212 42071 41507 42088 42077 42105 42095 42094 42091 46184 44763 45801 42108 43977 43972 43311 44746 44208 46114 46121 43278 43297 43277 43300 43296 40581 41520 44573 41571 44266 44264 44269 44252 46192 46213 46205 46187 46220 44567 44572 44559 44279 44563 44560 44277 44281 44282 44569 44283 40563 45821 40577 41989 42013 46181 46179 46157 46180 41567 42067 42076 44738 41490 41482 41494 41546 44749 44755 44754 44231 44227 44229 44787 41554 42886 42033 42040 46102 46109 42064 41532 46103 45798 45808 45806 42012 42011 43288 43287 42007 42008 42027 42907 46123 46146 46156 41515 42001 46210 41565 44550 44553 44221 44228 43247 44251 44248 44234 41569 42890 43262 43250 44814 45787 44774 40573 45780 44552 41483 41479 41498 41488 42915 41997 44831 44798 44828 44773 46115 46124 46122 40541 45835 45828 45776 45826 45827 45804 45830 45823 45825 45829 45824 45810 44745 41547 43308 44209 44758 44766 41541 42909 42107 42096 42100 43970 40558 42913 42911 42875 42877 40532 40569 42883 41555 41574 44830 41533 41535 41506 41510 41513 44801 44813 44815 44795 40543 40544 46237 40535 44258 44233 44247 44244 44256 44250 44241 44259 41518 46155 46163 44272 44270 44273 41575 42066 43246 43266 44274 44808 44821 40523 44800 41529 42015 41994 42009 42021 46120 42109 40530 42910 41519 44780 44734 40529 44762 44574 44562 44554 44759 46174 45785 44816 44817 44748 45771 43242 43268 46171 46169 46176 40552 40553 41481 46119 46148 42897 43252 43251 43256 43253 45836 45838 45846 45847 45840 42089 46118 45795 46132 46137 45822 40559 44806 44771 45768 44807 44805 45770 45767 45831 42026 40531 43294 43305 43295 43299 43298 43307 43310 43263 43968 42041 42039 42049 42044 42056 42050 42038 42055 42057 42052 42045 42047 42053 42046 42048 42061 42062 41990 41987 42036 42035 42079 42090 42882 44811 45860 46107 45853 45861 46111 46105 46106 46101 45858 46104 46110 46098 42916 42904 44551 44561 44557 46152 45839 44796 44743 44285 42103 42893 45805 46224 43287 42004 40551 40554 42920 42922 42918 41525 40566 42037 42042 44235 44240 44236 44207 44239 43313 44238 44243 42873 43978 43976 46129 40547 42912 40571 44732 42104 43272 43303 45820 45819 44253 44257 45778 43244 46100 46226 42906 44818 45773 44284 45814 45807 45786 41566 40576 40567 46135 46112 46142 46140 42098 41540 44265 40540 41512    44556 44280 46130 46170 44768 40542 40561 40564 40034MF 41493
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Australia, Belgium, Brazil, Canada, Chile, China, Denmark, France, Germany, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, and Venezuela.
  • Product Description
    Linvatec LS 7500, 300 Watt Xenon Light Source || Catalog Numbers: LS7500, LS7500L (loaner), || LS7500R (refurbished)
  • Manufacturer
    Linvatec Imaging

Manufacturer

Linvatec Imaging
  • Manufacturer Address
    Linvatec Imaging, 749 Ward Dr, Santa Barbara CA 93111-2918
  • Source
    USFDA