CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report

Artiste, Oncor and Primus with syngo RT Therapist recalled

Siemens Medical Solutions USA is recalling Artiste, Oncor and Primus with syngo RT Therapist, distributed nationwide in the US. The recall was initiated on 9 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: N/A S/N: 10736, 10737, 10822, 10850, 10886,10843, 10865,10025 Software version 4.3.1 MR3

Quantity recalled8 units US

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-0472-2023
FDA event ID: 91182
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Nov 2022
FDA classified: 9 Dec 2022
Reported: 21 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

9 Nov 2022	Recall initiated by company
9 Dec 2022	Classified by FDA	+30 days
21 Dec 2022	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

When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter

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

ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

Where it was distributed

US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.

Nationwide California Iowa Louisiana Nebraska Nevada Ohio South Carolina

Questions about this recall

Why was it recalled?

When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter

Which lots are affected?

UDI: N/A S/N: 10736, 10737, 10822, 10850, 10886,10843, 10865,10025 Software version 4.3.1 MR3

Where was it sold?

US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.

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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