Elekta Inc Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Brand
Elekta Inc
Lot Codes / Batch Numbers
Serial Numbers:SH00106, SH00120, SH00149, SH00160, SH00165, SH00110, SH00143, SH00150, SH00161, SH00166, SH00111, SH00144, SH00157, SH00162, SH00167, SH00112, SH00147, SH00158, SH00163, SH00168, SH00114, SH00148, SH00159, SH00164 and SH00178. UDI 7340048304887.
Products Sold
Serial Numbers:SH00106, SH00120, SH00149, SH00160, SH00165, SH00110, SH00143, SH00150, SH00161, SH00166, SH00111, SH00144, SH00157, SH00162, SH00167, SH00112, SH00147, SH00158, SH00163, SH00168, SH00114, SH00148, SH00159, SH00164 and SH00178. UDI 7340048304887.
Elekta Inc is recalling Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neur due to A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal ch. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
Recommended Action
Per FDA guidance
Elekta Inc., notified customers on 04/01/2020 via Urgent Important Field Safety Notification letter. The letter identified the affected products and customers were instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible but no later than 30 days from receipt. Elekta will replace all defective Instrument Carriers. Replacement units will be sent to affected facilities as soon as available. The firm sent an additional letter on 05/06/2020 with the following information: All Instrument Carriers included in this IFSN will be replaced by Elekta. While you await your replacement, Elekta has formulated an additional mandatory in-field test that must be carried out on every defective device. This test must be carried out by a trained technician/engineer or equivalent at your hospital or by Elekta, and the defective device must pass the full test for the continued use of the product. Thus, if your defective Instrument Carrier should fail to pass this test, it must be immediately removed from use.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026