FDA Class II Recall: Brand Name: Leksell Vantage Arc System REF: 1053958 by Elekta, Inc.

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Elekta, Inc. and the affected product is described in FDA's record as: Brand Name: Leksell Vantage Arc System REF: 1053958. FDA's stated reason for the recall is: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.. The recall is tracked under FDA recall number Z-2006-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Brand Name: Leksell Vantage Arc System REF: 1053958 -- and the recall number Z-2006-2026. If it matches, stop using or distributing it and contact Elekta, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Elekta, Inc.’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Elekta, Inc.: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

Elekta, Inc. recalled Brand Name: Leksell Vantage Arc System REF: 1053958. FDA's record states the reason for recall as: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.. The recall is logged under FDA recall number Z-2006-2026 with a Class II classification.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

Related enforcement actions