| Date Initiated by Firm | March 25, 2021 |
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| Create Date | April 15, 2021 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1427-2021 |
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| Recall Event ID |
87666 |
| 510(K)Number | K200569 |
|---|
| Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
|
| Product | RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613) |
|---|
| Code Information |
Software version: 9A, 9B, 10A, 10B |
Recalling Firm/
Manufacturer |
RAYSEARCH LABORATORIES AB
Sveavagen 9
Stockholm Sweden
|
Manufacturer Reason
for Recall | Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On 03/25/2021, RaySearch Laboratories issued an Urgent Medical Device Correction notice via email to their customer notifying them of an issue found with the display of flags in RayTreat. Flags edited in RayCare after a patient has been checked in, may not be updated in RayTreat. |
|---|
| Quantity in Commerce | 1 system |
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| Distribution | US Nationwide in the state of TN. |
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| 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.
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| 510(K) Database | 510(K)s with Product Code = MUJ
|
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