| |
Class 2 Device Recall RaySearch |
 |
| Date Initiated by Firm |
December 30, 2021 |
| Create Date |
March 08, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0732-2022 |
| Recall Event ID |
89631 |
| 510(K)Number |
K211867
|
| Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
|
| Product |
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy.
Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 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 , 9.2.0.483 .
Including Service Paks:
Product name (build number) UDI-DI
RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013
RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082
RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075
RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242
RayStation/RayPlan 7 (7.0.0.19) 07350002010068
RayStation/RayPlan 8A (8.0.0.61) 07350002010112
RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136
RayStation/RayPlan 8B (8.1.0.47) 07350002010129
RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204
RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235
RayStation/RayPlan 9A (9.0.0.113) 07350002010174
RayStation/RayPlan 9B (9.1.0.933) 07350002010266
RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297 |
| Code Information |
Software:
6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 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, 9.2.0.483
UDI:
07350002010013
07350002010082
07350002010075
07350002010242
07350002010068
07350002010112
07350002010136
07350002010129
07350002010204
07350002010235
07350002010174
07350002010266
07350002010297
07350002010013
07350002010082
07350002010075
07350002010242
07350002010068
|
Recalling Firm/
Manufacturer |
RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
|
Manufacturer Reason
for Recall |
If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running
|
FDA Determined
Cause 2 |
Software design |
| Action |
RaySearch issued Field Safety Notice, Medical Device Correction #90375 via
E-mail, on 30 December 2021. Letter stated reason for recall, health risk and action to take:
Do not change the primary image set while the cine loop is running.
" If the primary image set has been changed while the cine loop is running, restart
RayStation/RayPlan to restore correct behavior.
" Educate planning 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.
Solution.
This issue is resolved in RayStation/RayPlan versions 10A and higher (subject to market clearance in somemarkets). If customers wish to continue using versions of RayStation/RayPlan 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.
Please confirm that you have received this FSN.
If you want to attach a signed reply form to the email, please fill in the below. You can also fax this form to Fax: +1-631-828-2137 (US only).
For regulatory information, please contact quality@raysearchlabs.com. |
| Quantity in Commerce |
75 Licenses |
| Distribution |
US Nationwide distribution. |
| Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
| 510(K) Database |
510(K)s with Product Code = MUJ and Original Applicant = RaySearch Laboratories AB (publ)
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