—#180666

Product

Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K171123, K190887
Affected lot / code info: 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.

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Elekta Inc
Address: 1450 Beale St, Ste 205, Saint Charles, Missouri 63303

Distribution

Distribution pattern: US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.

Timeline

Recall initiated: 2020-03-30
Posted by FDA: 2020-04-29
Terminated: 2024-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180666. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.