Elekta Leksell Vantage Stereotactic System Recall for Locking Mechanism Defect
Elekta is recalling 51 Leksell Vantage Stereotactic Systems because the locking mechanism at the Instrument Carrier and Arc interface may not function properly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a mechanical defect that may not function properly without reporting specific injuries or hospitalizations, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta Instrument AB is recalling 51 Leksell Vantage Stereotactic Systems (UDI/GTIN 7340048304887) due to a defect in the locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc. The agency has classified this as a Class II recall.
The defect may cause the locking mechanism to not function properly. The affected devices are distributed across multiple U.S. states, including Massachusetts, Illinois, New Hampshire, North Carolina, Utah, Ohio, Florida, Minnesota, Texas, New York, Louisiana, Arizona, Montana, and West Virginia, as well as numerous international locations.
Healthcare facilities should contact Elekta Instrument AB for instructions on how to address the defect. The recall covers specific serial numbers listed in the agency's official documentation.
The recalled product
- Product
- Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
- Manufacturer
- Elekta Instrument AB
- Hazard
- Affected units
- 51
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers: SH00026
- SH00049
- SH00061
- SH00082
- SH00092
- SH00111
- SH00028
- SH00050
- SH00072
- SH00084
- SH00094
- SH00118
- SH00029
- SH00052
- SH00073
- SH00085
- SH00095
- SH00121
- SH00030
- SH00054
Distribution
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