Leksell Vantage Stereotactic System recallZ-1826-2020 · Elekta Inc · initiated Mar 30, 2020
Class II Terminated All recalls posted in April 2020
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
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
FDA root cause category: Process design
What the company is doing
Elekta Inc., notified customers on 04/01/2020 via Urgent Important Field Safety Notification letter. The letter identified the affected products and customers were instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible but no later than 30 days from receipt. Elekta will replace all defective Instrument Carriers. Replacement units will be sent to affected facilities as soon as available. The firm sent an additional letter on 05/06/2020 with the following information: All Instrument Carriers included in this IFSN will be replaced by Elekta. While you await your replacement, Elekta has formulated an additional mandatory in-field test that must be carried out on every defective device. This test must be carried out by a trained technician/engineer or equivalent at your hospital or by Elekta, and the defective device must pass the full test for the continued use of the product. Thus, if your defective Instrument Carrier should fail to pass this test, it must be immediately removed from use.
Recall details
- Recall number
- Z-1826-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 30, 2020
- Posted by the FDA
- Apr 29, 2020
- Recalling firm
- Elekta Inc
- Quantity
- 25 units.
- Product code
- HAW
- FDA submissions
- K171123, K190887
- Distribution
- US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.
Product description
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Code information (models, lots, serial numbers)
Serial Numbers:SH00106, SH00120, SH00149, SH00160, SH00165, SH00110, SH00143, SH00150, SH00161, SH00166, SH00111, SH00144, SH00157, SH00162, SH00167, SH00112, SH00147, SH00158, SH00163, SH00168, SH00114, SH00148, SH00159, SH00164 and SH00178. UDI 7340048304887.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Leksell Vantage Stereotactic System 1055007Elekta Instrument AB · Neurological stereotaxic Instrument1 recall1 report
Product lines
Other devices under the same FDA submission
9 devices cleared under K171123, 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 1054958Elekta Instrument AB · Neurological stereotaxic Instrument2 recalls0 reports
- Leksell Vantage Stereotactic System 1054956Elekta Instrument AB · Neurological stereotaxic Instrument1 recall8 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
- Leksell Vantage Stereotactic System 1053958Elekta Instrument AB · Neurological stereotaxic Instrument14 reports
- Leksell Vantage Stereotactic System 1051800Elekta Instrument AB · Neurological stereotaxic Instrument6 reports
- Leksell Vantage Stereotactic System 1072447Elekta Instrument AB · Neurological Stereotaxic Instrument2 reports
- Leksell Vantage Stereotactic System 1519676Elekta Instrument AB · Neurological stereotaxic Instrument1 report
- Leksell Vantage Stereotactic System 1054250Elekta Instrument AB · Neurological stereotaxic Instrument1 report
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 18, 2026. Text above is shown as published by the FDA.
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