Recall Z-2442-2020
Elekta Instrument AB · initiated June 10, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Codes / lots: Serial numbers: SH00026, SH00049, SH00061, SH00082, SH00092, SH00111, SH00028, SH00050, SH00072, SH00084, SH00094, SH00118, SH00029, SH00052, SH00073, SH00085, SH00095, SH00121, SH00030, SH00054, SH00074, SH00086, SH00097, SH00123, SH00032, SH00055, SH00077, SH00087, SH00099, SH00127, SH00033, SH00057, SH00078, SH00088, SH00100, SH00162, SH00041, SH00058, SH00079, SH00089, SH00102, SH00044, SH00059, SH00080, SH00090, SH00105, SH00045, SH00060, SH00081, SH00091, SH00108
Reason for recall
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2442-2020
- Initiated
- June 10, 2020
- Terminated
- August 27, 2024
- Product code
- HAW – Neurological Stereotaxic Instrument
- 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
- Recalling firm
- Elekta Instrument AB, Stockholm