Z-1742-2024Class II
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System
RaySearch Laboratories AB (publ) / initiated 2024-03-28 / Open, Classified / root cause: software
RAYSEARCH LABORATORIES AB began a recall of RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System on . FDA classified it as Class II and gives the reason as "Potential for reported SSD to be too high". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-1742-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- RaySearch Laboratories AB (publ)
- Product
- RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
- Product code
- MUJ System, Planning, Radiation Therapy Treatment
- Reason for recall
- Potential for reported SSD to be too high.
- Root cause tag
- software
- FDA root cause
- Software design
- Action
- A Field Safety Notice for Medical Device Correction #133261, dated 3/28/24, was sent to consignees via email. Consignees were provided the instructions to use the Measure Tool to measure the distance in the patient view to make sure the reported SSD value is correct if it is to be used for patient setup or other critical tasks. If the SSD value is found to be incorrect, small changes to the isocenter, beam angles or the affected ROI's geometry can be made until the correct value is achieved. Consignees are to inform planning staff and all users of the workarounds provided in the Field Safety Notice. Consignees are to inspect their product and identify if installed units possess the affected software versions. Consignees are to reply to the recall notification confirming that they read and understood the Field Safety Notificaiton. RaySearch is to deploy a new version of RayStation/RayPlan to correct the issue, to be released in April 2024. The provided Field Safety Notice is to be maintained with affected units. Consignees with any questions are to contact [email protected].
- Quantity in commerce
- 9 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.
- Product codes and lots
- UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10 Software Revisions: RayStation/RayPlan 8A and 8A Service Pack 1; Expiration Date: 2023-10-04.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1741-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1742-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1743-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1744-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1745-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1746-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1747-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1748-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1749-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1750-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1751-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1752-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.