Elekta Recalls Leksell Vantage Stereotactic System Instrument Carriers
Elekta Inc is recalling 25 Leksell Vantage Stereotactic System Instrument Carriers because a faulty locking piece may not meet required locking force standards.
What this means for you
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 involves a medical device with a structural defect (locking force) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta Inc is recalling 25 units of the Leksell Vantage Stereotactic System Instrument Carrier, part of the Leksell Vantage Arc (1053958). This neurological stereotaxic instrument is used in medical procedures.
The recall was initiated after an internal check found that a faulty locking piece on the Instrument Carrier does not fulfill the requirement of locking force to the Arc. The affected units were distributed nationwide in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA, and MT.
Healthcare facilities and users should identify affected units by checking for the specific serial numbers listed in the recall notice (SH00106 through SH00178) and UDI 7340048304887. Users should contact Elekta Inc for instructions on how to proceed with the recall.
The recalled product
- Product
- Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
- Manufacturer
- Elekta Inc
- Affected units
- 25
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:SH00106
- SH00120
- SH00149
- SH00160
- SH00165
- SH00110
- SH00143
- SH00150
- SH00161
- SH00166
- SH00111
- SH00144
- SH00157
- SH00162
- SH00167
- SH00112
- SH00147
- SH00158
- SH00163
- SH00168
Distribution
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