Reported Apr 5, 2023 · Ongoing
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments
Elekta Instrument AB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta Instrument AB · Kungstensgatan 18 · Stockholm, N/A · N/A
Is this the product you have?
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments
12 of 12 products
| Model / number | Product as published |
|---|---|
A2800-26 | (1) , Backlund Catheter Insertion Needle Kit III |
A2800-15 | (2) , Backlund Catheter Insertion Needle Kit I |
A2600-01 | (3) , Backlund Haematoma Evacuator Kit |
A2200-01 | (4) , Salcman Twist Drill Kit I |
907801 | (5) , Insertion Cannula Kit |
50398-01 | (6) , Catheter Inserter Needle 1,5 |
307165 | (7) , Insertion Cannula 190 MM |
60377-02 | (8) , Twist Drill 3.2 MM |
60377-01 | (9) , Twist Drill 2.1 MM |
50376-01 | (10) , Salcman Twist Drill 2.1/3.2 |
14001050 | (11) , Catheter Inserter Needle 2,6 |
1002248 | and (12) , Frame G w Straight/Curved Front. |
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 07340048301305(1) 07340048301305 2 07340048300285(2) 07340048300285 3 07340048301220(3) 07340048301220 4 07340048301145(4) 07340048301145 5 07340048300315(5) 07340048300315 6 07340048308618(6) 07340048308618 7 07340048308632(7) 07340048308632 8 07340048308571(8) 07340048308571 9 07340048308564(9) 07340048308564 10 07340048308601(10 07340048308601 11 07340048308625(11) 07340048308625 12 07340048306348and (12) 07340048306348. - Amount recalled
- 70 devices
Where it was sold
Why it was recalled
The incorrect IFU was distributed with the devices.
This product could cause temporary or reversible health problems — stop using it.
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