The Recall Desk

Manufacturer

RaySearch America Inc

2 recalls in our database name RaySearch America Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2023-07-05

Of the 2 recalls from RaySearch America Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-2039-2023·2023-07-05

    RayStation Radiation Therapy Software Recalled for Incorrect Dose Calculation

    RaySearch America is recalling RayStation radiation therapy treatment planning software due to a software bug that produces incorrect dose calculations. The error could lead to inappropriate treatment plans being approved for patient use.

    Product
    Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0850-2022·2022-04-06

    Medical software recall: RayStation radiation therapy dose calculation errors

    RayStation and RayPlan radiation therapy planning software may calculate incorrect radiation doses due to a source-to-skin distance calculation error. The FDA Class II recall affects 149 units distributed in the US.

    Product
    RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2), RayS
    Category
    Medical Device
    Distribution
    Distributed nationwide