Leksell Vantage Stereotactic System recallZ-2006-2026 · Elekta, Inc. · initiated Mar 19, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
FDA root cause category: Device Design
What the company is doing
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, firmly attached, and locked in place. 5. Inspect the equipment for visible signs of damage before clinical use. Do not use damaged equipment for any purpose. If you suspect that any part is damaged, contact your Elekta representative immediately. 6. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. 7. Advise the appropriate personnel working with this product, on the content of this letter. If the product has been transferred to another facility, please provide them with a copy of this communication.
Recall details
- Recall number
- Z-2006-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 19, 2026
- Posted by the FDA
- Apr 29, 2026
- Recalling firm
- Elekta, Inc.
- Quantity
- 768 (364Left/364Right)
- Product code
- HAW
- FDA submissions
- K190887
- 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, Republic of Kuwait Lithuania Mexico Morocco Netherlands New Zealand Norway Pakistan Panama Poland Portugal Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Kingdom
Product description
Brand Name: Leksell Vantage Arc System REF: 1053958
Code information (models, lots, serial numbers)
Lot Code: Arc System: UDI:07340048304856 Parts of Arc System: Left Z-Slide: Serial Numbers :UDI: 07340048304818 00001 00625 Right Z-Slide: UDI: 07340048304801/ Serial Numbers: 00001 00675
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Leksell Vantage Stereotactic System 1054958Elekta Instrument AB · Neurological stereotaxic Instrument2 recalls0 reports
- Leksell Vantage Stereotactic System 1051632Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Vantage Stereotactic System 1051631Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K190887 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Leksell Vantage Stereotactic System 1072447Elekta Instrument AB · Neurological Stereotaxic Instrument2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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