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Class 2 Device Recall RayStation |
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| Date Initiated by Firm |
May 26, 2020 |
| Create Date |
June 24, 2020 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2426-2020 |
| Recall Event ID |
85796 |
| 510(K)Number |
K190387
|
| Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
|
| Product |
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2 |
| Code Information |
Software versions 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 and 9.2.0.483 |
Recalling Firm/
Manufacturer |
RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
|
Manufacturer Reason
for Recall |
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
On May 26, 2020, the firm notified affected customers of the product issue via emailed Field Safety Notices. Customers were made aware of the following issues: 1) When only a single beam record is received for a specific beam, the delivered Gantry angle is hidden and only the planned Gantry angle is shown, and 2) For users of RayCare 3B and RayStation RayTreat 9B (including all service packs), if a manual import is necessary, the treatment record must be imported manually into both RayStation and PACS.
ACTIONS TO BE TAKEN BY THE USER
" Be aware that the Gantry angle column in the first row for each beam in the Beam delivery results
always shows the planned Gantry angle and does not indicate which Gantry angle was used when
delivering a beam.
" If treatment records are not successfully sent from the delivery machine to RayTreat:
o always manually record all the beams that were delivered before signing off the session.
o import all treatment records into both RayStation and RayPACS.
" Take extra precautions when delivering a continuation session based on a manually recorded or
offline imported treatment records to ensure that the correct amount of radiation is delivered during
the continuation.
" Educate treatment 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.
The firm plans to resolve these issues in the next version of RayStation, which the firm estimates will be available in June 2020. If customers wish to continue using versions of RayStation
affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can
choose to upgrade to the new version once it becomes available for clinical use. |
| Quantity in Commerce |
12 |
| Distribution |
Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = MUJ and Original Applicant = RaySearch Laboratories AB (publ)
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