The Recall Desk
HighFDA (Devices)·Z-1399-2018·Announced 2018-04-25

Siemens Oncor Expression Linear Accelerator Software Update Recall

Siemens is recalling two Oncor Expression linear accelerators to update software and reduce the risk of collision during automated cancer treatments.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall addresses a risk-of-harm product (collision during radiation therapy) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling two units of the ONCOR Expression Digital Linear Accelerator, Model No. 07360717. The recall involves serial numbers 5245 and 5353. These devices are used to deliver x-ray radiation for the therapeutic treatment of cancer.

The recall is being conducted to update the Control Console software. This update is intended to reduce the risk of collision when delivering automatically sequenced treatments that involve automatic movements of the gantry and/or the treatment table.

The affected devices were distributed worldwide, including nationwide in the United States in the states of AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY, as well as Puerto Rico. International distribution included Nassau. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the software update.

The recalled product

Product
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.
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial no: 5245 5353

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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