Elekta Instrument AB recalls

3 official recalls and safety alerts involving Elekta Instrument AB since 2023-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Elekta Instrument AB or the relevant agency.

  1. 2024-11-13
  2. US
    Drugs & medicalClass I

    Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF…

    Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No…

    FDA · DeviceElekta Instrument ABUS: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,Official notice →
  3. 2024-04-24
  4. US
    Drugs & medicalClass I

    Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes…

    Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same…

    FDA · DeviceElekta Instrument ABUS and Australia, Austria, Belgium, France, Germany, Greece, Italy,…Official notice →
  5. 2023-04-05
  6. US
    Drugs & medicalClass II

    Elekta Instrument AB recalls Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund…

    The incorrect IFU was distributed with the devices.

    FDA · DeviceElekta Instrument ABUS Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS,…Official notice →