CLASS II ONGOING Device recall · Reported 1 Apr 2020 · FDA Enforcement Report
RayStation standalone recalled by Raysearch Laboratories Ab
Raysearch Laboratories Ab is recalling RayStation standalone, distributed nationwide in the US. The recall was initiated on 4 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1598-2020
- FDA event ID
- 85255
- Recalling firm
- Raysearch Laboratories Ab, Stockholm, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Mar 2020
- FDA classified
- 26 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 4 Mar 2020 | Recall initiated by company | |
| 26 Mar 2020 | Classified by FDA | +22 days |
| 1 Apr 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.
Where it was distributed
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIdahoIllinoisLouisianaMassachusettsMarylandMaineMichiganMissouriMississippi
Questions about this recall
Is RayStation standalone recalled?
Yes. Raysearch Laboratories Ab recalled RayStation standalone on 4 Mar 2020. The recall is Class II and its status is Ongoing. Recall number Z-1598-2020.
Why was it recalled?
Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.
Which lots are affected?
Systems with software versions: 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.7.6.7 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 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 or 9.1.0.933
Where was it sold?
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Raysearch Laboratories Ab
All 115| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | RayCare 2024A SP4 recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Other | Nationwide |
| Device | CLASS II | RayCare 2024A SP1 recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Other | Nationwide |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Device Malfunction | |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Device Malfunction | |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories Ab | Device Malfunction |
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