CLASS II Device recall · Reported 20 Aug 2014 · FDA Enforcement Report

Siemens Linear Accelerators of type Artiste, Oncor recalled

Siemens Medical Solutions USA is recalling Siemens Linear Accelerators of type Artiste, Oncor, and Primus with Automatic Sequenced, distributed nationwide in the US. The recall was initiated on 28 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesmaterial numbers: 01940035, 04504200, 05672977, 05693908, 05857912, 05857920, 08139789, 08319758, 08490005, 08515520, 09401654, 09401746, 09822693, with serial numbers below 3094.

Quantity recalled160

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-2174-2014
FDA event ID: 68507
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2014
FDA classified: 10 Aug 2014
Reported: 20 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

28 May 2014	Recall initiated by company
10 Aug 2014	Classified by FDA	+74 days
20 Aug 2014	Published in enforcement report	+10 days

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

Reason for recall

A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.

Where it was distributed

Nationwide and ROW, including Canada and Mexico.

Nationwide

Questions about this recall

Is Siemens Linear Accelerators of type Artiste, Oncor, and Primus with Automatic Sequenced recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Linear Accelerators of type Artiste, Oncor, and Primus with Automatic Sequenced on 28 May 2014. The recall is Class II and its status is Terminated. Recall number Z-2174-2014.

Why was it recalled?

Which lots are affected?

material numbers: 01940035, 04504200, 05672977, 05693908, 05857912, 05857920, 08139789, 08319758, 08490005, 08515520, 09401654, 09401746, 09822693, with serial numbers below 3094.

Where was it sold?

Nationwide and ROW, including Canada and Mexico.

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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