The Recall Desk

Manufacturer

Elekta Instrument AB

5 recalls in our database name Elekta Instrument AB as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
2
Most recent
2024-11-13

Of the 5 recalls from Elekta Instrument AB we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (40%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • SevereFDA (Devices)·Z-0227-2025·2024-11-13

    Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination

    Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465,
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-1397-2024·2024-04-24

    Elekta Disposable Biopsy Needles Recalled for Microscopic Internal Debris

    Elekta recalled disposable biopsy needles from batch 837838839 that may contain microscopic stainless steel debris inside. The sterility of the needles has not been affected, and this issue has been reported from only one site.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 91
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1309-2023·2023-04-05

    Leksell Stereotactic System Recall: Incorrect Instructions Distributed with Devices

    Elekta Instrument AB is recalling 70 Leksell Stereotactic System neurosurgical devices due to incorrect Instructions for Use being distributed with the devices. Incorrect documentation for neurosurgical equipment could impact proper device use.

    Product
    Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2442-2020·2020-07-08

    Elekta Leksell Vantage Stereotactic System Recall for Locking Mechanism Defect

    Elekta is recalling 51 Leksell Vantage Stereotactic Systems because the locking mechanism at the Instrument Carrier and Arc interface may not function properly.

    Product
    Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1412-2019·2019-05-29

    Elekta Recalls Leksell GammaPlan 11.1 Software Due to Margin Overestimation

    Elekta Instrument AB is recalling Leksell GammaPlan 11.1 software because the margin tool overestimates treatment margins in certain areas.

    Product
    Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide