Agency classClass IIOur severity:High FDA (Devices)·Z-1826-2020·Announced 2020-05-06

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.

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 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
Category: Medical Device — Surgical Instrument
Hazard: structural-defect
mechanical-failure
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

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Same manufacturer · Elekta Inc

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