Recall Z-2006-2026 ยท HAW Neurological Stereotaxic Instrument
Elekta, Inc.
Brand Name: Leksell Vantage Arc System REF: 1053958
| Date | Apr 29, 2026 (initiated Mar 19, 2026) |
| Status | Open, Classified |
| Reason | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. |
| Root cause | Device Design |
| Action | On March 19, 2026 Elekta issued a "Urgent: Medical Device Recall" notification via e-mail. Elekta asked consignees 1. Before each operation, products should be cleaned, sterilized (unless specified otherwise), and checked for proper functionality. 2. Make sure to examine all scales and angles to make sure that they are correctly set and securely fixed before proceeding. 3. Make sure to obtain a second person in the OR room to read the coordinate settings so as to ensure they are correct and check they are securely locked. 4. Before you continue, check that all parts are assembled correctly, |
| Quantity | 768 (364Left/364Right) |
| Distribution | US: AR AZ CA CO DC FL GA ID IL KS MA MD ME MO MT NC NE NH NJ NM NV NY OH OK PA SC TX UT VA WA WI WV OUS: Algeria Australia Austria Azerbaijan Belgium China Colombia Costa Rica Croatia Czech Republic Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Israel Italy Japan Korea, Repub |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190887 | Leksell Vantage Stereotactic System Elekta Instrument AB, Aug 1, 2019 |