Device Recall RayStation

Build numbers 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14 and 4.7.0.15

Radiology Devices

2

No

Nationwide Distribution.

RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. || RayStation is a software system designed for treatment planning and analysis of radiation therapy.

Software Version (Build numbers) 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, or 4.0.3.4

Radiology Devices

2

No

US Nationwide Distribution

RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment || Product Usage: || RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

software build numbers are 4.7.0.15 or 4.7.1.10

Radiology Devices

2

No

Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.

Radiation Therapy Treatment Planning System software || RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.

3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13 or 4.7.4.4

Radiology Devices

2

No

**Domestic** AR, AZ, CA, CT, CO, DE, FL, GA, IL, LA, MI, MD, MS, MA, NY, NV, NJ, OH, OR, PA, NC, RI, TN, WA & Washington D.C; **Internationally** Algeria, Australia, Austria, Belgium, Canada, China, France, French Polynesia, Germany, Iran, Italy, Japan, Netherlands, New Zealand, Norway, Republic of Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom

RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.

Software build numbers: 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 and 5.0.2.35

Radiology Devices

2

No

California, Connecticut, Delaware, Florida, Hawaii, Maine, Missouri, New York, Ohio, Texas and Washington

RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.