Recall Z-2442-2020 ยท HAW Neurological Stereotaxic Instrument
Elekta Instrument AB
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
| Date | Jun 10, 2020 |
| Status | Terminated |
| Reason | The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly. |
| Root cause | Device Design |
| Action | The firm notified their consignees on 06/10/2020 by email. The notice explained the problem and provided directions on the removal of the spring. The firm offered assistance with the removal and provided the following contact: Neurosupport@elekta.com. |
| Quantity | 51 devices |
| Distribution | MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171123 | Leksell Vantage Stereotactic System Elekta Instrument AB, Sep 15, 2017 |