Elekta Instrument AB

Complete recall history across all FDA and CPSC categories — 5 total recalls

Elekta Instrument AB 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 (5)

FDA medical device enforcement actions by Elekta Instrument AB

Date Product Reason Class
Sep 25, 2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... Elekta has become aware that Disposable Biopsy Needles can contain some micro... Class I
Mar 15, 2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... Elekta has become aware that Disposable Biopsy Needles (911933) from one batc... Class I
Mar 1, 2023 Instructions for Use for the following Leksell Stereotactic System and Leksel... The incorrect IFU was distributed with the devices. Class II
Jun 10, 2020 Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 The locking mechanism at the interface of the Instrument Carrier and the Leks... Class II
Jun 27, 2018 Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-bas... The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin... 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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