FDAJune 10, 2020device
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
What to do
FDA enforcement status: Terminated
Brands named
elekta instrument abelektaelekta instrument
UPCs
7340048304887
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMOSAIQ Oncology Information System2026-05-21
- FDABrand Name: Leksell Vantage Arc System REF: 10539582026-03-19
- FDAeTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-1572026-03-02
- FDAeTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-1512026-03-02
- FDAeTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-1562026-03-02
- FDAeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-1522026-03-02
- FDAeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-1502026-03-02
- FDAeTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-1582026-03-02
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