Z-2442-2020 Class II Terminated
FDA device recall Z-2442-2020 was initiated by Elekta Instrument AB on Jun 10, 2020 and is designated Class II. Reason for recall: The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly. The recall status is terminated (terminated Aug 27, 2024). Affected quantity: 51 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 8, 2020
- Initiation Date
- Jun 10, 2020
- Termination Date
- Aug 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51 devices
Product Description
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Reason for Recall
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Distribution Pattern
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
Code Information
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