Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk
Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.
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 medical device defect that can lead to patient mistreatment, which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling three units of Syngo RT Therapist software. The software is used with Siemens ARTISTE, ONCOR, and PRIMUS linear accelerator systems to deliver radiation for cancer treatment.
The recall is due to a potential error where the combination of CTVision with syngo RT Therapist or syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying these incorrect offsets can lead to patient mistreatment. Cone Beam imaging is not affected by this problem.
The affected units are distributed in Utah, Wisconsin, and New York. The specific units are identified by model number 08162815 and serial numbers 10010, 10046, and 10586. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this issue.
The recalled product
- Product
- Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS 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
- Affected units
- 3
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 (4)
- model # 08162815
- serial #s 10010
- 10046
- 10586
Distribution
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