RAYSEARCH LABORATORIES AB: RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System 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.

Recall number

Z-0038-2017

Recalling firm

RAYSEARCH LABORATORIES AB

Product

RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System 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.

Status

Terminated

Initiated

2016-09-01

Posted

not on file

Terminated

2019-06-11

Reason

RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with the dose calculation when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline (External ROI) in RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0).

Root cause

Under Investigation by firm

Action

RaySearch sent a Field Safety Notice, on September 1, 2016, (RSL-D-61-301, dated 9/5/2016), was sent by e-mail to all affected customers. ACTIONS TO BE TAKEN BY THE USER Do not use ROIs of type Fixation or Support within the patient outline. Always use other ROI types for material override within the External ROI. A small overlap with the External ROI is acceptable if the Fixation or Support ROI is mainly outside the External ROI. Please educate planning staff and all users about this workaround. Inspect your product and identify all installed units with the above software version number, then confirm you have read and understood this notice (contact information below). SOLUTION A correction of these issues will be available in the next version of RayStation, scheduled for market release in December 2016. In the meantime, this field safety notice is distributed to all customers. Until a corrected version has been installed, all affected users must maintain awareness of this field safety notice. TRANSMISSION OF THIS FIELD SAFETY NOTICE This notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as this version of RayStation is in use to ensure effectiveness of the workaround.

Quantity

USA: 522 units, OUS 846 units

Distribution

Nationwide distribution

Lot, serial or model codes

Build Numbers: 2.5.0.144, 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, 4.0.3.42, 4.3.0.14, 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 or 5.0.2.35.

510(k) numbers

["K160093"]

PMA numbers

not on file

Product code

MUJ

Firm FEI

3007774465

Firm city

Stockholm

Firm state

not on file

Firm country

Sweden

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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