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Maquet Cardiovascular Us Sales, Llc recalls The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible
Recalled July 15, 2015 · FDA recall Z-1990-2015 · Maquet Cardiovascular Us Sales
Hazard
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 Class II
Units
646 units
Sold at
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.
Description
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.
Product
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(s)
Maquet Cardiovascular Us Sales, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →