Siemens Medical Solutions Recalls Elekta MOSAIQ Software Due to Safety Risk
Siemens Medical Solutions is recalling Elekta MOSAIQ Oncology Information System software versions below 2.41 due to a potential safety risk identified by the manufacturer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the source text identifies a 'potential safety risk' for a medical device used in cancer treatment without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Elekta MOSAIQ Oncology Information System software versions below 2.41. The recall involves 101 units distributed worldwide. The software is used in conjunction with SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems, which are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
The recall was initiated because the manufacturer, IMPAC Medical Systems, Inc., identified a potential safety risk associated with the MOSAIQ Oncology Information System. The source text does not specify the nature of the safety risk, the number of affected patients, or any reported injuries or illnesses.
Healthcare facilities and users of the affected software should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the potential safety risk. The recall number is Z-1077-2013.
The recalled product
- Product
- ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 101
Distribution
Distribution scope not specified by the agency.
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