Cancer treatment linear accelerator systems recalled for wrong-site dosing risk
Siemens recalled 13 ARTISTE linear accelerator systems for cancer treatment due to a potential safety issue that could cause radiation to be delivered to the wrong treatment site.
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: This is an FDA Class II recall for a medical device with potential to cause serious patient harm. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 13 ARTISTE with syngo RT Therapist linear accelerator systems (Model 8162815) used to deliver targeted X-ray and electron radiation for cancer treatment.
The systems have a potential safety issue that, under specific preconditions, may cause a user to select the wrong treatment site. If this occurs, radiation dose could be delivered to the wrong isocenter, potentially resulting in serious patient injury.
The affected units were distributed across Iowa, Louisiana, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, and South Dakota. Hospitals and cancer treatment centers using the affected serial numbers should contact Siemens Medical Solutions USA, Inc. for guidance on remedial actions.
The recalled product
- Product
- ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 13
Distribution
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