Recall record at a glance
| Official record | Z-1990-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Maquet Cardiovascular Us Sales, LLC |
| Report date | Jul 15, 2015 |
| Recall initiation date | May 29, 2015 |
| Quantity | 646 units |
| Location | Wayne, NJ, United States |
Official 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.
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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