Siemens ARTISTE Linear Accelerator Recall for Dark Current Radiation Risk
Siemens is recalling 26 ARTISTE Linear Accelerator systems due to a potential dark current radiation risk during specific IMRT treatments.
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 agency classification is FDA Class II, and the hazard involves significant radiation dose accumulation, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 26 units of SIEMENS brand ARTISTE Linear Accelerator (Linac) systems. The recall involves systems equipped with any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. These systems are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
The recall is issued due to a safety risk regarding a potentially existing dark current radiation phenomenon. In cases where treatment plans involve many long periods of field shape changes, the dose due to dark current radiation may sum up to a significant value.
The affected units were distributed worldwide, including in the United States (specifically FL, NC, NY, PA, TN, UT, and WI) and in Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand. Specific serial numbers for the affected units are listed in the agency's official recall record.
The recalled product
- Product
- SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 26
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 (20)
- Serial Numbers: 5364
- 5419
- 5640
- 5737
- 5823
- 5830
- 5166
- 5342
- 5416
- 5444
- 5479
- 5485
- 5628
- 5745
- 5746
- 5762
- 5763
- 5764
- 5772
- 5781
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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