Canon Medical Wireless Flat Panel Detector Recall for Image Transmission Failure
Canon Medical System is recalling 43 wireless flat panel detectors because they may fail to transmit images, requiring repeated attempts to acquire data.
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 hazard involves a software malfunction that prevents image transmission, which is a functional defect rather than a direct physical injury risk. No injuries or illnesses are reported, and the issue is resolved by repeating the operation or canceling, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Canon Medical System, USA, INC. is recalling 43 units of the DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) medical devices. The recall was initiated after it was found that when an operator performs radiography using the wireless flat panel detector, a message window may appear on the monitor stating that image transmission was not completed and that there is no image. The message window displays an 'OK' button to reacquire image data and a 'Cancel' button to cancel the reacquisition.
When the operator selects the 'OK' button, the same message window appears again. The operator may need to repeat the operation several times before finally selecting the 'Cancel' button to quit the reacquisition mode. This issue prevents the successful transmission of the acquired image data on the first attempt.
The affected units were distributed domestically in AR, FL, GA, PA, IL, LA, MI, NC, NJ, NY, OH, TN, TX, UT, VT, WI, and WV, and internationally in Australia, Canada, The Netherlands, South Korea, and Malaysia. The recall covers specific serial numbers manufactured between January 2013 and October 2016. Users should contact Canon Medical System for further instructions on how to resolve the issue.
The recalled product
- Product
- DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 43
Distribution
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