The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to…
Medical device recall Z-1990-2015. Published in FDA’s Enforcement Report on Jul 15, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 15, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 646 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
646 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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,…
Every code shown here, 1,995 characters
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,…
FDA’s list runs to 4,099 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 29, 2015.
- FDA classified it on Jul 7, 2015.
- FDA’s Enforcement Report published it on Jul 15, 2015.
- FDA terminated it on Apr 7, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Maquet Cardiovascular Us Sales, Llc, of Wayne, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,099 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.