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Elekta Instrument AB Recalls
5 recalls on record · May 29, 2019 to November 13, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 13, 2024Medical DevicesFDA
Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inne
Hazard: 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 debris has been found on the outer parts of the biopsy needles.
April 24, 2024Medical DevicesFDA
Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6
Hazard: 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 material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.
April 5, 2023Medical DevicesFDA
Elekta Instrument AB recalls Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A
Hazard: The incorrect IFU was distributed with the devices.
July 8, 2020Medical DevicesFDA
Elekta Instrument AB recalls Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Hazard: The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
May 29, 2019Medical DevicesFDA
Elekta Instrument AB recalls Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife
Hazard: The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.