Reported Jul 8, 2020 · Terminated
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Elekta Instrument AB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta Instrument AB · Kungstensgatan 18 · Stockholm, N/A · N/A
Is this the product you have?
- Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
- Lot codes and dates
- Serial numbers
SH00026SH00049SH00061SH00082SH00092SH00111SH00028SH00050SH00072SH00084SH00094SH00118SH00029SH00052SH00073SH00085SH00095SH00121SH00030SH00054SH00074SH00086SH00097SH00123SH00032SH00055SH00077SH00087SH00099SH00127SH00033SH00057SH00078SH00088SH00100SH00162SH00041SH00058SH00079SH00089SH00102SH00044SH00059SH00080SH00090SH00105SH00045SH00060SH00081SH00091SH00108
- Serial numbers
- Amount recalled
- 51 devices
Where it was sold
Why it was recalled
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
This product could cause temporary or reversible health problems — stop using it.
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