Product Wiki · Recalls · U.S. FDA — Device Enforcement

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 — recall Z-2442-2020

U.S. FDA — Device Enforcement · Sweden · 2020-06-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2442-2020
Date of alert
2020-06-10
Country / jurisdiction
Sweden
Risk level
Class II
Notice type
recall
Brand
Elekta Instrument AB
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom
Barcode (EAN/GTIN)
7340048304887
Reported risk: The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.