Elekta, Inc. recalls Brand Name: Leksell Vantage Arc System REF: 1053958
See all recalls from Elekta, Inc. →Recalled Product
Brand Name: Leksell Vantage Arc System REF: 1053958
Hazard / Issue
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Issued by
FDA
Affected States: AR, AZ, CA, CO, DC, FL, GA, ID, IL, KS, MA, MD, ME, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TX, UT, VA, WA, WI, WV
Lot/Code Info: Lot Code: Arc System: UDI:07340048304856 Parts of Arc System: Left Z-Slide: Serial Numbers :UDI: 07340048304818 00001 00625 Right Z-Slide: UDI: 07340048304801/ Serial Numbers: 00001 00675
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Brand Name: Leksell Vantage →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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