Z-2442-2020Class II

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

Name: Z-2442-2020 Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Creator: Elekta Instrument AB
Published: 2020-06-10
License: https://open.fda.gov/license/

Elekta Instrument AB / initiated 2020-06-10 / Terminated / root cause: design

FDA source

Elekta Instrument AB began a recall of Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 on 2020-06-10. FDA classified it as Class II and gives the reason as "The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2442-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-10
Posted: 2020-07-10
Terminated: 2024-08-27
Recalling firm: Elekta Instrument AB
Product: Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Root cause tag: design
FDA root cause: Device Design
Action: The firm notified their consignees on 06/10/2020 by email. The notice explained the problem and provided directions on the removal of the spring. The firm offered assistance with the removal and provided the following contact: [email protected].
Quantity in commerce: 51 devices
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2442-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2442-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26

Product code HAW

K171123Class IILeksell Vantage Stereotactic SystemElekta Instrument AB / cleared 2017-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)