Siemens ONCOR Impression Linear Accelerator Software Update Recall
Siemens is recalling seven ONCOR Impression Digital 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 seven units of the ONCOR Impression Digital Linear Accelerator, Model No. 05857920. The device is intended 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 designed to reduce the risk of collision when delivering automatically sequenced treatments involving automatic movements of the gantry and/or the treatment table.
The affected units were distributed worldwide, including nationwide in the United States and internationally to Nassau. The specific serial numbers for the recalled units are 70-4143, 70-4296, 70-4235, 70-4344, 4021, 3878, and 5154. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the software update.
The recalled product
- Product
- ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 7
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:70-4143 70-4296 70-4235 70-4344 4021 3878 5154
Distribution
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.
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