Siemens Linear Accelerator Recall Due to Potential Patient Mistreatment
Siemens is recalling specific linear accelerator systems because a difficult-to-interpret calibration issue may have resulted in the mistreatment of cancer patients.
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 source text explicitly states that the issue 'may have resulted in mistreatment of patients,' which constitutes a significant injury report or risk of harm, meeting the criteria for a Severe (Score 4) classification under the rubric for significant injury reports.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Siemens MEVATRON series, PRIMART, PRIMUS, ONCOR, and ARTIST Linac Systems equipped with BEAMVIEW capability. The recall involves 1,956 customers worldwide, including locations in the United States and numerous international countries.
The recall was initiated because the information regarding FILM Mode calibration may have been difficult to interpret when translated. Siemens Healthcare CR / Radiation Oncology became aware that this issue may have resulted in the mistreatment of patients.
This recall is classified as Class II by the FDA. Affected customers who use the BEAMVIEW for position verification imaging on these systems should contact Siemens for further instructions.
The recalled product
- Product
- Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 1,956
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 (1)
- PRIMART (limited release) PRIMUS and/or ONCOR or ARTIST Linac Systems.
Distribution
Distributed nationwide across the United States.
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