RaySearch America Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 SerClass IIFeb 11, 2022Incorrect source to skin or surface distance (SSD) calculati	Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation	Class IIDevices	Feb 11, 2022
Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2,Class IIJan 22, 2021A software bug affecting results when using deep learning (D	A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions:	Class IIDevices	Jan 22, 2021