CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report

RayStation 8A Service Pack recalled by Raysearch Laboratories Ab

Raysearch Laboratories Ab is recalling RayStation 8A Service Pack 1, distributed nationwide in the US. The recall was initiated on 18 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI # 07350002010136 Build number: 8.0.1.10

Quantity recalledN/A

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-2345-2020
FDA event ID: 85723
Recalling firm: Raysearch Laboratories Ab, Stockholm, N/A
Classification: Class II
Status: Terminated
Recall initiated: 18 May 2020
FDA classified: 10 Jun 2020
Reported: 17 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

18 May 2020	Recall initiated by company
10 Jun 2020	Classified by FDA	+23 days
17 Jun 2020	Published in enforcement report	+7 days

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

Reason for recall

Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.

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 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

Where it was distributed

US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.

Nationwide Arizona California District of Columbia Florida Georgia Illinois Louisiana Massachusetts Maryland Missouri New Jersey Oklahoma Tennessee Texas Utah Virginia Washington

Questions about this recall

Is RayStation 8A Service Pack 1 recalled?

Yes. Raysearch Laboratories Ab recalled RayStation 8A Service Pack 1 on 18 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2345-2020.

Why was it recalled?

Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.

Which lots are affected?

UDI # 07350002010136 Build number: 8.0.1.10

Where was it sold?

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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