Canon Aquilion One CT Scanner Recall for System Interruption
Canon Medical System is recalling 35 Aquilion One CT scanners because a software error may interrupt scanning and prevent normal shutdown, causing loss of raw data.
What this means for you
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 hazard involves data loss and operational interruption rather than direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Canon Medical System, USA, INC. is recalling 35 units of the Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1. The recall involves specific serial numbers listed in the agency's structured product information.
The recall is due to a software error during the execution of the eXam Plan that may interrupt scanning. This error can prevent the system from being shut down normally, requiring the user to forcibly turn off the power and reboot the system. As a result, acquired raw data may be lost.
The affected devices were distributed to hospitals and facilities in 28 states, including government and military facilities, but were not distributed outside the United States. Consumers and healthcare providers should contact Canon Medical System for further instructions on resolving the issue.
The recalled product
- Product
- Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — CT Scanner
- Affected units
- 35
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)
- Canon Aquilion ONE GENESIS Edition
- Whole-Body X-Ray CT Scanner
- Model TSX-305A - Serial number 3LA1652001
- 3LA17Y2020
- 3LB1872025
- 3LA1762010
- 3LA1772012
- 3LA1762009
- 3LB1882026
- 3LA1752007
- 3LA1762008
- 3LA1772013
- 3LA1732006
- 3LA1772015
- 3LA1772014
- 3LA16Y2003
- 3LA1792017
- 3LA1782016
- 3LA1712005
- 3LB1832021
Distribution
Part of a larger recall action
This product is one of 8 recalled by Canon Medical System, 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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