FDA (Devices) recall action 85723

RAYSEARCH LABORATORIES AB recalled 15 products on 2020-06-17

The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.

Products: 15
Announced: 2020-06-17
Critical: 0
Units: —

Why these products were recalled

Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–15 of 15

HighFDA (Devices)··2020-06-17
RayStation 6 Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 6 software due to a calculation error that may underestimate radiation dose.
Product
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
HighFDA (Devices)··2020-06-17
RayStation 7 Software Recalled for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 7 software due to errors in dose calculation algorithms that may underestimate radiation dose.
Product
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
HighFDA (Devices)··2020-06-17
RayStation Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation software versions 4.0 to 5.0 Service Pack 2 due to a dose calculation error that may underestimate radiation dose.
Product
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
HighFDA (Devices)··2020-06-17
RayStation 6 Service Pack 3 Radiation Therapy Software Recall
RaySearch Laboratories is recalling RayStation 6 Service Pack 3 software due to a calculation error that could underestimate radiation dose.
Product
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
HighFDA (Devices)··2020-06-17
RayStation 8A Software Recall for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 8A Service Pack 1 software due to a dose calculation error that could underestimate radiation therapy doses.
Product
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
HighFDA (Devices)··2020-06-17
RayStation 9B Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 9B software due to a dose calculation error that could underestimate radiation therapy doses.
Product
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
SevereFDA (Devices)··2020-06-17
RayStation 5 Service Pack 3 Radiation Therapy Software Recalled
RaySearch Laboratories is recalling RayStation 5 Service Pack 3 software due to a dose calculation error that may underestimate radiation dose.
Product
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
HighFDA (Devices)··2020-06-17
RayStation 9B Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 9B Service Pack 1 due to a software error in dose calculation algorithms that could result in local underestimation of expected radiation dose.
Product
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
HighFDA (Devices)··2020-06-17
RayStation 8B Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 8B software due to errors in dose calculation algorithms that could underestimate radiation dose.
Product
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
HighFDA (Devices)··2020-06-17
RayStation 8A Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 8A software due to a defect in dose calculation algorithms that may underestimate radiation dose.
Product
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
SevereFDA (Devices)··2020-06-17
RayStation 8B Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 8B Service Pack 2 software due to a defect in dose calculation algorithms that could underestimate radiation dose.
Product
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
HighFDA (Devices)··2020-06-17
RayStation 6 Service Pack 1 Radiation Therapy Software Recall
RaySearch Laboratories is recalling RayStation 6 Service Pack 1 software due to a calculation error that may underestimate radiation dose.
Product
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
SevereFDA (Devices)··2020-06-17
RayStation 6 Service Pack 2 Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 6 Service Pack 2 software due to a calculation error that could underestimate radiation dose.
Product
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
SevereFDA (Devices)··2020-06-17
RayStation 9A Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 9A software due to errors in dose calculation algorithms that could underestimate radiation therapy doses.
Product
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states
HighFDA (Devices)··2020-06-17
RayStation 8B Service Pack 1 Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 8B Service Pack 1 due to a software error that could underestimate radiation dose.
Product
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Distribution
17 states