Every recall we track for Elekta Instrument AB — 5 in all — plus the complaints and injury reports the public filed about them.
Elekta recalls disposable biopsy needle kits for Leksell stereotactic systems due to potential microscopic stainless steel debris inside needles. This could cause injury during medical procedures. Affected kits have specific model numbers and batch codes.
Elekta recalls disposable biopsy needle kits with lot 837838839 for possible microscopic stainless steel debris inside needles. No sterility issues reported. Affected kits contain 6 inner boxes labeled REF 911761.
Elekta recalls specific Leksell Stereotactic System and neurosurgical instruments due to incorrect Instructions for Use distributed with devices. Affected items include Backlund Catheter Insertion Needle Kits and Haematoma Evacuator Kits with specific part numbers.
Elekta recalls specific Leksell Vantage Stereotactic System models due to potential improper locking mechanism function at the Instrument Carrier and Arc interface.
Elekta recalls Leksell GammaPlan 11.1 software due to systematic margin overestimation in certain treatment areas. Users should contact Elekta for updates.
