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

FDA device recall Z-1826-2020 · posted 2020-04-29 · Terminated

Recall details

Recalling firm

Elekta Inc

Reason for recall

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.

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

HAW

Quantity affected

25 units.

Distribution

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

Date initiated

2020-03-30

Date posted

2020-04-29

Date terminated

2024-04-10

Location

Saint Charles, MO

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