Siemens Recalls 80 Oncor Avant-Garde Radiation Therapy Systems for Software Update
Siemens Medical Solutions is voluntarily recalling 80 Oncor Avant-Garde radiation therapy systems to install a software update. The devices were distributed throughout the United States.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any hospitalizations, injuries, or deaths, and the reason is a software update, which aligns with the 'Moderate' criteria for voluntary precautionary recalls without reported serious harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is voluntarily recalling 80 units of the ONCOR" Avant-garde radiation therapy system (Device Model# 1940035). The recall was initiated on February 14, 2017, and was classified as Class II by the FDA. The reason for the recall is the need for a software update.
The affected devices were distributed throughout the United States. The recall was initiated by the firm and was terminated on December 18, 2017. Initial notification to facilities was sent via letter.
This recall involves a medical device used for radiation therapy. The specific hazard associated with the software update is not detailed in the provided source text, but the FDA classified the recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ONCOR" Avant-garde
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 80
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)
- Device Model# 1940035
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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