Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Instructions for Use for the following Leksell Stereotactic System and Recalled by Elekta Instrument AB Due to The incorrect IFU was distributed with the devices.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Elekta Instrument AB directly.
Affected Products
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front.
Quantity: 70 devices
Why Was This Recalled?
The incorrect IFU was distributed with the devices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Elekta Instrument AB
Elekta Instrument AB has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report