FDA Medical Device Recalls (openFDA)
Elekta Inc: Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
- Recall number
- Z-1826-2020
- Recalling firm
- Elekta Inc
- Product
- Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
- Status
- Terminated
- Initiated
- 2020-03-30
- Posted
- 2020-04-29
- Terminated
- 2024-04-10
- Reason
- 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.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 25 units.
- Distribution
- US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K171123","K190887"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1937649
- Firm city
- Saint Charles
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28