Device recall
Z-1397-2024: Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933…
FDA device recall · Class I · Elekta Instrument AB
Key facts
| Recall number (Z-number) | Z-1397-2024 |
|---|---|
| Recall event | 94197 |
| Product | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable… |
| Product code | HAW |
| Recalling firm | Elekta Instrument AB |
| Recall class | Class I |
| 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