Reported Apr 17, 2024 · Ongoing
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including…
Raysearch Laboratories Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RAYSEARCH LABORATORIES AB · Eugeniavagen 18c · Stockholm, N/A · N/A
Is this the product you have?
- RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
- Lot codes and dates
- 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)
- Version Number (Build Number/UDI)
- Amount recalled
- 154 units
Where it was sold
- Nationwide
Why it was recalled
A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
This product could cause temporary or reversible health problems — stop using it.
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