Linear accelerator software addresses potential wrong-site treatment risk
Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.
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: This is a Class II FDA recall involving high-risk potential for wrong-site radiation delivery in cancer treatment. Although no illnesses or injuries have been reported and the hazard is theoretical, the potential for serious harm to patients justifies a High severity rating.
Plain-English summary
Siemens Medical Solutions USA, Inc. has recalled ARTISTE, ONCOR, and PRIMUS linear accelerator systems running syngo RT Therapist software version 4.3.1 MR3 (Material Number 8162815). These devices deliver X-ray photon and electron radiation for cancer treatment.
A software usability issue in the site fraction group selection interface may allow operators to accidentally select the wrong treatment site. If this error occurs, radiation could be delivered to the wrong isocenter (treatment location) in the patient's body.
Eight units of the affected software version were distributed across California, Iowa, Louisiana, Nebraska, Nevada, Ohio, and South Carolina. The affected serial numbers are: 10736, 10737, 10822, 10850, 10886, 10843, 10865, and 10025.
Facilities using affected units should contact Siemens Medical Solutions for guidance on mitigation steps. Operators should verify site selection before each treatment delivery to prevent wrong-site radiation exposure.
The recalled product
- Product
- ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: 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
- Hazard
- wrong-site-treatment
- radiation-delivery-error
- user-interface-error
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 (8)
- UDI: N/A S/N: 10736
- 10737
- 10822
- 10850
- 10886
- 10843
- 10865
- 10025 Software version 4.3.1 MR3
Distribution
Distributed nationwide across the United States.
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