Z-2899-2020Class II

RayCare, device is stand-alone software -

Name: Z-2899-2020 RayCare, device is stand-alone software -
Creator: Raysearch Laboratories Ab
Published: 2020-07-29
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2020-07-29 / Open, Classified

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment... on 2020-07-29. FDA classified it as Class II and gives the reason as "When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2899-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-29
Posted: 2020-08-27
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.
FDA root cause: Under Investigation by firm
Action: Only 1 effected consignee who was emailed a field safety notice on 08/05/2020. This letter instructs the user to: Be aware that registration of a treatment image with a corresponding study with multiple series in the same frame of reference might block the offline image review. Verify the correctness of the data in RayCare PACS before using the data for any decision making. -Please educate staff and all users about this workaround. -Inspect your product and identify all installed units with the above software version number(s). -Confirm you have read and understood this notice by replying to the notification email.
Distribution: US Nationwide distribution including in the state of Tennessee.
Product codes and lots: Model #: 2C SP2, 2C SP3, 3A SP1, 3B and 4A Software Version: 2.2.2.30782 , 2.2.3.53423 , 3.0.1.43597 , 3.1.0.60341 , 4.0.0.60621"

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2899-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2899-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-02	2020-08-27

Product code MUJ

K200487Class IIRayCare 3.1RaySearch Laboratories AB (PUBL) / cleared 2020-06-10

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)