Recall Z-1826-2020 ยท HAW Neurological Stereotaxic Instrument
Elekta Inc
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
| Date | Apr 29, 2020 (initiated Mar 30, 2020) |
| Status | Terminated |
| 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 |
| Quantity | 25 units. |
| Distribution | US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT. |
| FDA record | Open on fda.gov |