Instructions for Use for the following Leksell Stereotactic System… — Class II medical device recall Z-1309-2023
Ongoing recall by Elekta Instrument AB, reported 2023-04-05, distributed nationwide. The incorrect IFU was distributed with the devices.
| Recall number | Z-1309-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Instrument AB, Stockholm, N/A, Sweden |
| Recall initiated | 2023-03-01 |
| Classified | 2023-03-30 |
| Reported by FDA | 2023-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 70 devices |
| UPC / GTIN / UDI-DI | 07340048300285, 07340048300315, 07340048301145, 07340048301220, 07340048301305, 07340048306348, 07340048308564, 07340048308571, 07340048308601, 07340048308618, 07340048308625, 07340048308632 |
| Model numbers | 1002248, 14001050, 307165, 50376-01, 50398-01, 60377-01, 60377-02, 907801, A2200-01, A2600-01, A2800-15, A2800-26 |
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.
Reason for recall
The incorrect IFU was distributed with the devices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1309-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.