Siemens Linear Accelerator Recall for Unvalidated Stereotactic Accessories
Siemens Medical Solutions is recalling nine Linear Accelerator units because they may be used with unvalidated stereotactic accessories.
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 involves a high-risk medical device used for cancer treatment where the use of unvalidated accessories poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling nine Siemens Linear Accelerator (LINAC) units. These devices are used to deliver X-ray radiation for the therapeutic treatment of cancer.
The recall was initiated because Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories that have not been validated as being compatible with Siemens LINAC models. The affected units are distributed in the states of Alabama, Maine, Pennsylvania, Illinois, and California.
Customers should contact Siemens Medical Solutions USA, Inc. to determine if their equipment is affected and to receive instructions regarding the use of compatible accessories.
The recalled product
- Product
- Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 9
Distribution
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