Siemens Medical Solutions Recalls 158 Radiation Therapy Machines
Siemens Medical Solutions is recalling 158 radiation therapy machines due to a potential safety risk of the gantry colliding with patients or treatment tables.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural/mechanical defect in a medical device that poses a risk of physical injury (collision) to patients, which aligns with the 'Severe' criteria for significant injury reports or structural defects in high-risk devices.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 158 units of radiation therapy machines, including the ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, and ARTISTE models. These devices are intended to deliver x-ray radiation for the therapeutic treatment of cancer.
The recall is issued because of a potential safety risk where the LINAC gantry could collide with the patient or the treatment table. This risk is associated with the use of automatically sequenced treatment delivery techniques utilizing the SIMTEC Auto Field Sequence Option.
The affected units were distributed nationwide. Siemens Medical Solutions USA, Inc. is the recalling firm. Consumers and healthcare providers should contact the manufacturer for further instructions regarding the recall and corrective actions.
The recalled product
- Product
- ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 158
Distribution
Distributed nationwide across the United States.
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