Elekta Instrument AB FDA Recalls

3 recalls on file across devices, 2 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inneClass ISep 25, 2024Elekta has become aware that Disposable Biopsy Needles can c	Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of th	Class IDevices	Sep 25, 2024
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6Class IMar 15, 2024Elekta has become aware that Disposable Biopsy Needles (9119	Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some mi	Class IDevices	Mar 15, 2024
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #AClass IIMar 1, 2023The incorrect IFU was distributed with the devices.	The incorrect IFU was distributed with the devices.	Class IIDevices	Mar 1, 2023