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.
The incorrect IFU was distributed with the devices.
Elekta has recalled 12 specific neurosurgical instruments and systems because they came with incorrect Instructions for Use. This could lead to improper use during medical procedures if the wrong instructions are followed.
The incorrect Instructions for Use could cause improper handling of the instruments during neurosurgical procedures. This might lead to errors in treatment or complications if the wrong instructions are followed by medical staff.
Medical professionals using Elekta's Leksell Stereotactic Systems and neurosurgical instruments are most at risk. Patients receiving these procedures may be affected if the incorrect instructions are used.
Check for part numbers listed in the recall: A2800-26, A2800-15, A2600-01, A2200-01, 907801, 50398-01, 307165, 60377-02, 60377-01, 50376-01, 14001050, or 1002248. Also look for UDI-DI codes: 07340048301305 through 07340048306348.
Verify if your instruments have the incorrect Instructions for Use by checking the part numbers and UDI-DI codes listed in the recall.
Elekta recalls 12 specific neurosurgical instruments including Backlund Catheter Insertion Needle Kits, Haematoma Evacuator Kits, and Salcman Twist Drill Kits with part numbers A2800-26 through 1002248.
Check for part numbers listed in the recall: A2800-26, A2800-15, A2600-01, A2200-01, 907801, 50398-01, 307165, 60377-02, 60377-01, 50376-01, 14001050, or 1002248. Also look for UDI-DI codes: 07340048301305 through 07340048306348.
The recall states the incorrect Instructions for Use were distributed, but no specific stop-use action is required. Check the instructions to ensure proper use.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1309-2023 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1309-2023 from Elekta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
