Events

Recall of Device Recall PowerLED, XTEN, and VOLISTA Surgical Light Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet Cardiovascular Us Sales, Llc.

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
    71351
  • Event Risk Class
    Class 2
  • Event Number
    Z-1990-2015
  • Event Initiated Date
    2015-05-29
  • Event Date Posted
    2015-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137391
  • 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, surgical, ceiling mounted - Product Code FSY
  • Reason
    Maquet suspension arms used with powerled/x-ten/volista surgical light systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.
  • Action
    Maquet Medical Systems sent an Urgent Medical Device Field Correction letter dated May 29, 2015, to all affected customers via Fedex. The letter identified the product the problem and the action needed to be taken by the customer. The customer was informed that the correction will include inspection of PowerLED / X-TEN / VOLISTA Surgical Light Systems mounted above the surgical table and replacement of the suspension arms if found to be defective. As a remedial measure, pending replacement of the defective suspensions, Maquet personnel will install a protective plastic strip at each junction where the arms are grinding. The correction will be performed by an authorized Maquet Service Technician. The customer will be contacted by a representative of the Maquet Service team to schedule an on-site inspection and possible service of the PowerLED / X-TEN / VOLISTA Surgical Light Systems. If the customer has any questions or require additional information, they can contact their local Maquet representative, or Maquet Customer Service at 1-888-627-8383 (option 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

Device

Device Recall PowerLED, XTEN, and VOLISTA Surgical Light Systems
  • Model / Serial
    Dual Arm: Part #569710902 - Serial Numbers: 15664, 15672 thru 15673, 15738 thru 15739, 15791, 15803, 15818 thru 15819, 15822 thru 15823, 15830, 15834 thru 15835, 15881, 15889, 15981, 16016, 16019, 16058 thru 16064, 16066 thru 16067, 16120, 16284, 16286 thru 16287, 20076 thru 20077, 20142, 20151 thru 20152, 20155 thru 20157, 20193 thru 20194, 20216 thru 20220, 20249, 20256, 20258, 20263, 20270 thru 20271, 20277, 20292, 20300 thru 20301, 20304, 20337 thru 20338, 20342 thru 20343, 20350, 20464, 20504 thru 20506, 20508 thru 20511, 20523, 40002 thru 40003, 40014 thru 40015, 40031 thru 40032 and 40034.  Part #567910904 - Serial Numbers: 13177, 13190 thru 13191, 13204, 13208, 13217, 13219 thru 13220, 13232, 13235 thru 13236, 13249, 13251 thru 13252, 13254 thru 13255, 13257 thru 13260, 13288, 20004, 20008, 20061, 20063, 20065 thru 20072, 20111 thru 20115, 20119 thru 20120, 20122, 40001 thru 40002 and 40011 thru 40013.  Part #567910906 - Serial Numbers: 14509 thru 14510, 20014, 20085, 20091, 20097, 20101 thru 20104, 20114 thru 20115, 20231, 20246 and 40016 thru 40017.  Part #567910913 - Serial Numbers:12353 thru 12370, 12381, 12391 thru 12394, 20000 thru 20004, 20013, 20019 thru 20020, 20028 thru 20029, 20031, 20043 thru 20201, 20131 thru 20133, 20144 thru 20151, 20154 thru 20155, 20161, 40005, 40007 thru 40008 and 40018 thru 40020.  Part #567910915 - Serial Numbers: 12646, 12648 thru 12652, 20026 thru 20027 and 40007.  Part #567910923 - Serial Numbers: 12908, 20009 thru 20014 and 20022 thru 20023.  Part #567910936 - Serial Numbers: 12150 thru 12152.  Part #567910938 - Serial Numbers: 12067, 20007 thru 20011 and 40000.  Part #567910957 - Serial Numbers: 12295 thru 12296, 12304, 12310, 12312, 12347, 12356 thru 12360, 12409 thru 12410, 12416, 20011, 20015 thru 20016, 20018, 20028, 20035, 20041, 20063, 20070, 40007 and 40009.  Part #567910958 - Serial Numbers: 12254 thru 12263, 12273 thru 12275, 20010 thru 20011 and 40001.  Part #567910961 - Serial Numbers: 12386 thru 12389, 12393, 12420 thru 12421, 12426 thru 12429, 12470, 12476 thru 12477, 12481 thru 12483, 12514, 12551 thru 12553, 12560, 20002, 20023, 20045 thru 20046, 20048 thru 20051, 20053, 20055 thru 20057, 20062, 20065 thru 20066, 20068 thru 20071, 20073, 20081, 20084 thru 20093, 20120, 20121, 20123 thru 20127, 20138, 20202, 20206, 20214 thru 20215, 20217 thru 20221, 20223 thru 20225, 20229, 40006 thru 40007, 40023 and 40049.  Part #567910964 - Serial Numbers: 12179 thru 12197, 12199, 12202 thru 12209, 20001 thru 20006, 20029, 20033 thru 20050, 20052 thru 20063, 20085 thru 20087, 40000 and 40002 thru 40003.  Part #567910968 - Serial Numbers: 12054 thru 12060, 20004 thru 20008, 20012 thru 20018, 20023 thru 20028, 20044 and 40002 thru 40005.  Part #567910970 - Serial Numbers: 12026 thru 12029, 12031 thru 12033, 12039 thru 12040 and 20005.  Part #567910971 - Serial Numbers: 12178, 12194, 12196, 12198 thru 12201, 12204, 12207, 12210 thru 12211, 20000 thru 20002, 20005 thru 20008, 20019 thru 20020, 20022 thru 20025, 20032 thru 20040, 20043, 20048 thru 20050, 20056 thru 20061, 20063 thru 20067, 20071 thru 20073, 20079, 20083 thru 20085, 20090 thru 20104, 20119, 20125 thru 20129, 40007 thru 40010, 40012 and 40019 thru 40022.  Part #567910986 - Serial Numbers: 10000, 10021 thru 10035, 20000 thru 20002 and 40000 thru 40004.  Part #567910990 - Serial Numbers: 40026 thru 40028.  Part #567910993 - Serial Number: 30005.  Part #567912907 - Serial Numbers: 10023, 10027, 20006 and 40001.  Part #567912908 - Serial Numbers: 10002, 10011, 20000 thru 20003 and 40000.  Part #567912909 - Serial Numbers: 10022, 2001 thru 20002 and 20006.  Part #567912911 - Serial Numbers: 10001 thru 10003, 20000 and 40000.  Part #567912912 - Serial Numbers: 20003 thru 20004, 20006 thru 20008 and 40000 thru 40006.  Part #567912913 - Serial Numbers: 10012, 20002 and 20004 thru 20005.  Triple Arm: Part #567910917 - Serial Numbers: 20000 thru 20001, 20008 and 20010 thru 20019.  Part #567910918 - Serial Numbers: 12664 and 20039 thru 20040.  Part #567910965 - Serial Numbers: 12102 thru 12103, 12105 thru 12109, 20006 thru 20007 and 20010 thru 20016.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Austria, Australia, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, China, Colombia, Croatia, Hungary, Indonesia, Ireland, Iraq, Jordan, Japan, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Greenland, Greece, Hong Kong, United Arab Emirate, United Kingdom, Kenya, Kuwait, Sri Lanka, Luxembourg, Libya, Mongolia, Martinique, Mexico, Malaysia, Namibia, Nigeria, Netherlands, Norway, Oman, Panama, Peru, Philippines, Pakistan, Poland, Saint Pierre and Miquelon, Portugal, Reunion, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Thailand, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Uruguay, Venezuela, Serbia, Yemen, Mayotte and South Africa.
  • Product Description
    The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Manufacturer Address
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA