PlainRecalls

Elekta, Inc.

Compiled from official public sources by the editorial team.

112 recalls on record · Latest: May 6, 2026

Elekta, Inc. Recall Insight

Elekta, Inc. appears on 112 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.110% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 6, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 12 entries, severity tagging shows 0 critical, 12 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 12 of 12 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (12). The date window on this page runs from Jul 18, 2012 to Sep 11, 2013.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Sep 11, 2013

DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

FDA Devices Moderate Jun 5, 2013

Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radi…

FDA Devices Moderate Apr 17, 2013

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Devices Moderate Mar 20, 2013

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment proces…

FDA Devices Moderate Mar 6, 2013

Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

FDA Devices Moderate Feb 27, 2013

Monaco RTP System. Radiation treatment planning.

FDA Devices Moderate Nov 7, 2012

MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic pa…

FDA Devices Moderate Oct 31, 2012

Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the pur…

FDA Devices Moderate Sep 26, 2012

Precise Digital Accelerator Delivery of radiation to defined target volumes

FDA Devices Moderate Sep 19, 2012

Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body …

FDA Devices Moderate Jul 18, 2012

Focal SIM Planning of radiation therapy

FDA Devices Moderate Jul 18, 2012

Monaco Product Usage: Planning of radiation therapy

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.