CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report

Oncor Expression, Digital Linear Accelerator recalled

Siemens Medical Solutions USA is recalling Oncor Expression, Digital Linear Accelerator, distributed nationwide in the US. The recall was initiated on 14 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial no: 5245 5353

Quantity recalled2

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-1399-2018
FDA event ID: 79766
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 14 Feb 2018
FDA classified: 17 Apr 2018
Reported: 25 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

14 Feb 2018	Recall initiated by company
17 Apr 2018	Classified by FDA	+62 days
25 Apr 2018	Published in enforcement report	+8 days

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

Reason for recall

Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

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

ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

Where it was distributed

Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.

Nationwide Alabama California Florida Georgia Illinois Indiana Kentucky Massachusetts Michigan Missouri Mississippi New Jersey New York Ohio Oklahoma Pennsylvania Puerto Rico Rhode Island South Carolina Tennessee

Questions about this recall

Is Oncor Expression, Digital Linear Accelerator recalled?

Yes. Siemens Medical Solutions USA recalled Oncor Expression, Digital Linear Accelerator on 14 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1399-2018.

Why was it recalled?

Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

Which lots are affected?

Serial no: 5245 5353

Where was it sold?

Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.

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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