FDA Recall
Terminated
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Recall: Z-2442-2020
·
Initiated June 10, 2020
Recall
- Recall Number
- Z-2442-2020
- Event Number
- 85836
- Firm
- Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden
- FEI Number
- 3002806883
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- June 10, 2020
- Terminated
- August 27, 2024
Description
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Reason
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
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: [email protected].
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
Quantity
51 devices