Leksell Vantage Arc System locking mechanism may not secure properly
Elekta, Inc. is recalling the Leksell Vantage Arc System because locking mechanisms may fail to properly secure to the Arc system, which could cause coordinate shifting during medical procedures.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm medical device (coordinate shifting during procedures could result in treatment errors), and the source does not report any actual illnesses or injuries. Per the rubric, the score is at most 3 when no adverse events have been reported and the hazard is potential.
Plain-English summary
Elekta, Inc. is recalling the Leksell Vantage Arc System (REF: 1053958). The locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
The recalled system was distributed in the United States across multiple states and internationally to Algeria, Australia, Austria, Azerbaijan, Belgium, China, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Kuwait, Lithuania, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and the United Kingdom. A total of 768 units were affected (364 Left Z-Slides and 364 Right Z-Slides).
Users of this equipment should contact Elekta, Inc. for further guidance regarding the locking mechanism defect and any corrective actions that may be necessary to ensure proper device operation.
The recalled product
- Product
- Brand Name: Leksell Vantage Arc System REF: 1053958
- Manufacturer
- Elekta, Inc.
Distribution
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