X-Ray C-Arm System Internal Board Defect Causes Abnormal Images
Canon Medical System X-ray C-arm systems may display abnormal images due to an internal board manufacturing defect, potentially preventing exam completion and requiring patients to be re-examined with alternative equipment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a real hardware defect in a medical device that produces abnormal diagnostic images, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.' No illnesses or injuries have been documented, which caps the score at 3 per the rubric. The defect could potentially impact diagnostic accuracy.
Plain-English summary
Canon Medical System's X-ray C-arm systems, used for radiographic and fluoroscopic studies in interventional settings, may display abnormal images such as horizontal stripes. This is caused by a manufacturing change in the internal board. The defect may prevent the completion of an ongoing examination or require patients to be re-examined using an alternative X-ray system.
At least one affected device (UDI-DI 04987670100192, Serial Number B1E22X2005) was distributed to facilities in California and Louisiana.
Patients and healthcare providers who believe they have an affected X-ray system should contact Canon Medical System for evaluation and repair or replacement of the internal board.
The recalled product
- Product
- The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and proce
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 1
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 (2)
- UDI-DI: 04987670100192
- Serial Number: B1E22X2005
Distribution
Part of a larger recall action
This product is one of 2 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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