Z-1482-2024 Class II Ongoing
Recalled by RAYSEARCH LABORATORIES AB
— Stockholm, N/A
FDA device recall Z-1482-2024 was initiated by RAYSEARCH LABORATORIES AB on Feb 23, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 154 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 17, 2024
- Initiation Date
- Feb 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 154 units
Product Description
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
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 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.
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),
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1482-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.