Elekta, Inc. recall records

23 reported ongoing

23 records in this archive. Latest source date May 21, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.

Class IIReported ongoing

Distribution: Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bol...

Official source for Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam...
FDA device enforcement

Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

Class IIReported ongoing

Distribution: Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, ...

Official source for Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

Reasons in these listed records

  • Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
  • A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
  • Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

These examples come from this result page and are not a ranking of every recall reason.

Checking Elekta, Inc.

Is there a recall on elekta, inc. right now?

This archive contains 23 records, including 23 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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