Reported May 6, 2020 · Terminated
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological…
Elekta Inc.
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 Inc · 1450 Beale St Ste 205 · Saint Charles, MO · 63303
Is this the product you have?
- Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
- Lot codes and dates
- Serial Numbers
SH00106SH00120SH00149SH00160SH00165SH00110SH00143SH00150SH00161SH00166SH00111SH00144SH00157SH00162SH00167SH00112SH00147SH00158SH00163SH00168SH00114SH00148SH00159SH00164 and SH00178. UDI 7340048304887
- Serial Numbers
- Amount recalled
- 25 units.
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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