X-ray fluoroscopy system may display abnormal images due to detector board defect
Canon Medical's INFX-8000F X-ray system may display abnormal horizontal stripe patterns due to a manufacturing change in the flat panel detector's internal board, potentially preventing exam completion.
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 3/5 (High).
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: FDA Class II recall with no reported injuries. The manufacturing defect impairs diagnostic imaging and may necessitate repeat X-ray examinations, raising concern for diagnostic delays and additional radiation exposure.
Plain-English summary
Canon Medical System's INFX-8000F, a fluoroscopic and fluorographic X-ray system, is being recalled due to a manufacturing change made by supplier VAREX to the internal board of the X-ray flat panel detector. This change has resulted in systems displaying abnormal images, including horizontal stripe patterns.
When this defect occurs, it may prevent the radiologist or technician from completing an ongoing diagnostic examination. If the equipment fails to produce adequate images, the patient may need to be re-examined using another X-ray system, resulting in additional radiation exposure and diagnostic delay.
Two units with affected serial numbers BGE2292016 and BGE2362017 have been distributed in California and Louisiana. Affected facilities should contact Canon Medical System, USA, INC. for instructions on board replacement or system servicing.
The recalled product
- Product
- The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of…
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 2
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: 04987670100208. Serial Number: BGE2292016
- BGE2362017
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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