Device product
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
Z-1482-2024
Product summary
- Event
- Event 94153
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 154 units
- Official record key
device-enforcement:Z-1482-2024
Official wording
Reason: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
Code information: Version Number (Build Number/UDI): 8B (8.1.0.47/07350002010129), 8B SP1 (8.1.1.8/07350002010204), 8B SP2 (8.1.2.5/07350002010235), 9A (9.0.0.113/07350002010174), 9A SP1 (9.0.1.142/07350002010488), 9B (9.1.0.933/07350002010266), 9B SP1 (9.2.0.483/07350002010297), 10A (10.0.0.1154/07350002010303), 10A SP1 (10.0.1.52/07350002010365), 10A SP2 (10.0.2.10/07350002010655), 10B (10.1.0.613/07350002010310), 10B SP1 (10.1.1.54/07350002010471), 11A (11.0.0.951/07350002010389), 11A SP1 (11.0.1.29/07350002010433), 11A SP2 (11.0.3.116/07350002010440), 11A SP3 (11.0.4.15/07350002010631), 11B (12.0.0.932/07350002010426), 11B SP1 (12.1.0.1221/07350002010495), 11B SPC1 (12.1.1.41/07350002010587), 11B SP2 (12.0.3.68/07350002010501), 11B SPC2 (12.1.2.91/07350002010617), 11B SP3 (12.0.4.12/07350002010600), 11B SPC3 (12.1.3.162/07350002010662), 11B SPC4 (12.1.4.113/07350002010709), 11B SPC5 (12.1.5.60/07350002010747), 11B SPT1 (12.3.0.119/07350002010570), 12A (13.0.0.1547/07350002010549), 12A SP1 (13.1.0.144/07350002010679), 12A SP2 (13.1.1.89/07350002010730), 2023B (14.0.0.3338/07350002010556), 2024A (15.0.0.430/07350002010723),
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hong Kong S.A.R., Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, P.R. China, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom.
Derived failure modes
-
Unknown
A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.