RAYSEARCH LABORATORIES AB: RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.

Hazard

A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.

Details from the source

Reason for recall: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant. Distribution: 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, T Quantity: 154 units Lot/code info: 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),

UPC codes

07350002010129, 07350002010204, 07350002010235, 07350002010174, 07350002010488, 07350002010266, 07350002010297, 07350002010303, 07350002010365, 07350002010655, 07350002010310, 07350002010471, 07350002010389, 07350002010433, 07350002010440, 07350002010631, 07350002010426, 07350002010495, 07350002010587, 07350002010501, 07350002010617, 07350002010600, 07350002010662, 07350002010709, 07350002010747, 07350002010570, 07350002010549, 07350002010679, 07350002010730, 07350002010556, 07350002010723

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.