Z-1826-2020Class II

Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological...

Name: Z-1826-2020 Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological...
Creator: Elekta Inc
Published: 2020-03-30
License: https://open.fda.gov/license/

Elekta Limited / initiated 2020-03-30 / Terminated / root cause: manufacturing process

FDA source

Elekta Inc began a recall of Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument on 2020-03-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1826-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-30
Posted: 2020-04-29
Terminated: 2024-04-10
Recalling firm: Elekta Limited
Product: Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 25 units.
Distribution: US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1826-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1826-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29

Product code HAW

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)