Device recall
Z-1309-2023: Instructions for Use for the following Leksell Stereotactic System and Leksell…
FDA device recall · Class II · Elekta Instrument AB
Key facts
| Recall number (Z-number) | Z-1309-2023 |
|---|---|
| Recall event | 91780 |
| 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… |
| Product code | HAW |
| Recalling firm | Elekta Instrument AB |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K152558 |
| FEI number | 3002806883 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database