CLASS II ONGOING Device recall · Reported 21 Apr 2021 · FDA Enforcement Report
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service recalled
Raysearch Laboratories AB is recalling RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service, distributed nationwide in the US. The recall was initiated on 25 Mar 2021 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-1427-2021
- FDA event ID
- 87666
- Recalling firm
- Raysearch Laboratories AB, Stockholm, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Mar 2021
- FDA classified
- 15 Apr 2021
- Reported
- 21 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 25 Mar 2021 | Recall initiated by company | |
| 15 Apr 2021 | Classified by FDA | +21 days |
| 21 Apr 2021 | 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
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
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 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)
Where it was distributed
US Nationwide in the state of TN.
Questions about this recall
Why was it recalled?
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Which lots are affected?
Software version: 9A, 9B, 10A, 10B
Where was it sold?
US Nationwide in the state of TN.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories AB | Device Malfunction | |
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