Siemens Linear Accelerators Recalled for Unauthorized Component Safety Risks
Siemens Medical Solutions is recalling 320 linear accelerators because unauthorized third-party components may cause patient or operator injury and dose calculation errors.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect may result in 'serious injury' and 'overdose,' which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or potential.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 320 units of various Siemens Linear Accelerator models, including the ARTISTE, ONCOR, PRIUS HI, and MEVATRON series. These devices are used to deliver x-ray radiation for the therapeutic treatment of cancer. The recall covers units distributed worldwide, including the United States, Canada, and Mexico.
The recall is issued because the use of unauthorized third-party components on these linear accelerators may lead to patient or operator injury and damage to the equipment. Additionally, the dark current dose associated with these components must be considered in overall dose calculations; failure to do so may result in an overdose and serious injury. The use of these components can also potentially compromise the customer warranty.
Hospitals and medical facilities with these specific serial numbers should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the issue.
The recalled product
- Product
- Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 320
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 (18)
- 3986
- 5087
- 70-4119
- 70-4144
- 70-4262
- 70-4343
- 4078
- 5120
- 5170
- 5282
- 5506
- 70-4146
- 3287
- 5527
- 2958
- 3855
- 5517
- 3753
Distribution
Distributed nationwide across the United States.
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