medical MODERATE Updated 2023-04-05

Elekta Instrument AB recalls Instructions for Use for the following Leksell Stereotactic

See all recalls from Elekta Instrument AB →

Recalled Product

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.

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Hazard / Issue

The incorrect IFU was distributed with the devices.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: (1) 07340048301305; (2) 07340048300285; (3) 07340048301220; (4) 07340048301145; (5) 07340048300315; (6) 07340048308618; (7) 07340048308632; (8) 07340048308571; (9) 07340048308564; (10 07340048308601; (11) 07340048308625; and (12) 07340048306348.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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