Z-2351-2020Class II

RayStation 9B Service Pack 1, UDI # 07350002010297 -

Name: Z-2351-2020 RayStation 9B Service Pack 1, UDI # 07350002010297 -
Creator: Raysearch Laboratories Ab
Published: 2020-05-18
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2020-05-18 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments on 2020-05-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2351-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-18
Posted: 2020-06-10
Terminated: 2021-08-06
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: On May 18, 2020, RaySearch Laboratories emailed an Urgent Field Safety Notice, Medical Device Correction #60564 letter to their customers. The letter listed the following actions to be taken by the users: always use the MC dose engine for final dose calculation, in robustness analysis, and dose tracking if possible (the MC dose engine is available in versions RayStation 6.0 and later); if the pencil beam dose engine is used for final dose calculation, ensure that all spots intersect the External ROI as seen in the Beams Eye View (BEV) of the Plan optimization module; if they do not, expand the External ROI so that all spots do intersect the External ROI, and re-optimize the plan if necessary; if the MC dose engine is used for final dose calculation, and hot spots related to tangential fields are observed, expand the External ROI so that the central axis of all spots intersect the External ROI and re-optimize the plan; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the above software version number(s). RaySearch Laboratories asked all customers to confirm that they have read and understood the notice by replying to the notification email.
Distribution: US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
Product codes and lots: UDI # 07350002010297 Build number: 9.2.0.483

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2351-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2339-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2340-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2341-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2342-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2343-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2344-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2345-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2346-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2347-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2348-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2349-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2350-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2351-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2352-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10
Z-2353-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10

Product code MUJ

K190387Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2019-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)