| Date Initiated by Firm | May 20, 2026 |
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| Date Posted | July 01, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2647-2026 |
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| Recall Event ID |
99141 |
| 510(K)Number | K242992 |
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| Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
|
| Product | RayCare 2024A SP4. Oncology Information Systems. |
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| Code Information |
Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.
|
| FEI Number |
3007774465
|
Recalling Firm/
Manufacturer |
RAYSEARCH LABORATORIES AB
Eugeniavagen 18c
Stockholm Sweden
|
| For Additional Information Contact | Pierpaolo Sesana
0046-85-1053000 |
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Manufacturer Reason
for Recall | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | A Field Safety Notice, Medical Device Correction #175428 dated 6/2/26 was emailed to consignees. The notice advises consignees to ensure clear verbal or procedural communication when updating the beam set delivery note, avoid making changes from any location other than the control room when treatment is ongoing, avoid relying on beam set delivery note for conveying critical information. Additionally, consignees are to ensure planning staff and users are educated of the provided workaround. Consignees are to verify the software version of their units and reply to the emailed notification. A software update is scheduled for August 2026 to address this issue. Consignees with questions can contact quality@raysearchlabs.com. |
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| Quantity in Commerce | 3 units |
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| Distribution | Worldwide - US Nationwide distribution. |
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| 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
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