CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report

Leksell Vantage Stereotactic System recalled by Elekta Instrument AB

Elekta Instrument AB is recalling Leksell Vantage Stereotactic System, distributed in 14 states. The recall was initiated on 10 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers: SH00026, SH00049, SH00061, SH00082, SH00092, SH00111, SH00028, SH00050, SH00072, SH00084, SH00094, SH00118, SH00029, SH00052, SH00073, SH00085, SH00095, SH00121, SH00030, SH00054, SH00074, SH00086, SH00097, SH00123, SH00032, SH00055, SH00077, SH00087, SH00099, SH00127, SH00033, SH00057, SH00078, SH00088, SH00100, SH00162, SH00041, SH00058, SH00079, SH00089, SH00102, SH00044, SH00059, SH00080, SH00090, SH00105, SH00045, SH00060, SH00081, SH00091, SH00108

Quantity recalled51 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2442-2020
FDA event ID: 85836
Recalling firm: Elekta Instrument AB, Stockholm, N/A
Classification: Class II
Status: Terminated
Recall initiated: 10 Jun 2020
FDA classified: 26 Jun 2020
Reported: 8 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

10 Jun 2020	Recall initiated by company
26 Jun 2020	Classified by FDA	+16 days
8 Jul 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

Where it was distributed

MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom

Arizona Florida Illinois Louisiana Massachusetts Minnesota Montana North Carolina New Hampshire New York Ohio Texas Utah West Virginia

Questions about this recall

Why was it recalled?

The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

Which lots are affected?

Serial numbers: SH00026, SH00049, SH00061, SH00082, SH00092, SH00111, SH00028, SH00050, SH00072, SH00084, SH00094, SH00118, SH00029, SH00052, SH00073, SH00085, SH00095, SH00121, SH00030, SH00054, SH00074, SH00086, SH00097, SH00123, SH00032, SH00055, SH00077, SH00087, SH00099, SH00127, SH00033, SH00057, SH00078, SH00088, SH00100, SH00162, SH00041, SH00058, SH00079, SH00089, SH00102, SH00044, SH00059, SH00080, SH00090, SH00105, SH00045, SH00060, SH00081, SH00091, SH00108

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Elekta Instrument AB

All 5

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS I	Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recalled	Elekta Instrument AB	Foreign Material	11 states
24 Apr 2024Device	CLASS I	Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recalled	Elekta Instrument AB	Foreign Material
5 Apr 2023Device	CLASS II	Instructions for Use for the following Leksell Stereotactic recalled	Elekta Instrument AB	Other	Nationwide
29 May 2019Device	CLASS II	Leksell GammaPlan recalled by Elekta Instrument AB	Elekta Instrument AB	Other	Nationwide

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