Elekta Inc

Complete recall history across all FDA and CPSC categories — 10 total recalls

Elekta Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (10)

FDA medical device enforcement actions by Elekta Inc

Date Product Reason Class
Feb 28, 2023 Monaco RTP System. Used to make treatment plans for patients with prescr... Re-optimization, after adding contours without forced density outside the ext... Class II
Sep 14, 2021 Elekta Monaco - Product Usage: used to make treatment plans for patients with... Contour changes can be saved on an unintended image set. In addition, these c... Class II
Jul 26, 2021 Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 If a couch is removed while a plan is loaded, and then added back to the Stud... Class II
Apr 16, 2020 Elekta MONACO RTP Sytem, radiation treatment planning software system - Produ... The Monaco RTP Radiation Treatment Planning System may change the shape and v... Class II
Mar 30, 2020 Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vant... A faulty locking piece of the Instrument Carrier that does not fulfil the req... Class II
Nov 22, 2019 Monaco Radiation Treatment Planning System (RTP) System Monaco is using the incorrect energy when optimizing and calculating dose. Class II
Sep 4, 2019 Monaco RTP System, 5.40 Unity, radiation treatment planning system Product... It is possible that the forced electron density settings will be changed for ... Class II
Sep 4, 2019 Monaco RTP System, 5.50/5.51, radiation treatment planning system Product ... It is possible that the forced electron density settings will be changed for ... Class II
Jul 3, 2019 Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Plann... When creating 3D plans using either MU or Dose weighting modes, if the user c... Class II
Sep 1, 2017 Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments. Incorrect DICOM mapping of the exported collimator or couch angles from ERGO,... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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