CLASS II ONGOING Device recall · Reported 31 Mar 2021 · FDA Enforcement Report

RayCare 3B 1.0.60341) recalled by Raysearch Laboratories Ab

Raysearch Laboratories Ab is recalling RayCare 3B 1.0.60341), distributed nationwide in the US. The recall was initiated on 3 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesS/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220;

Quantity recalled1 unit

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-1281-2021
FDA event ID: 87471
Recalling firm: Raysearch Laboratories Ab, Stockholm, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 3 Mar 2021
FDA classified: 19 Mar 2021
Reported: 31 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Medical Software

Timeline

3 Mar 2021	Recall initiated by company
19 Mar 2021	Classified by FDA	+16 days
31 Mar 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

Product as listed by the FDA

RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.

Where it was distributed

US Nationwide distribution in the state of TN.

Nationwide Tennessee

Questions about this recall

Is RayCare 3B 1.0.60341) recalled?

Yes. Raysearch Laboratories Ab recalled RayCare 3B 1.0.60341) on 3 Mar 2021. The recall is Class II and its status is Ongoing. Recall number Z-1281-2021.

Why was it recalled?

Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

Which lots are affected?

S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220;

Where was it sold?

US Nationwide distribution 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 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.

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