Canon Medical INFX-8000C Tableside Console PWB Requires Replacement
Canon Medical has recalled 12 INFX-8000C tableside consoles due to a printed circuit board that may require replacement. Though procedures may be delayed, x-ray operations can continue using alternative controls.
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: This is a Class II recall with no reported injuries or hospitalizations. The PWB issue may cause procedural delays, but fallback controls allow operations to continue, making this primarily a functional rather than safety-critical issue.
Plain-English summary
Canon Medical System, USA, Inc. is recalling 12 INFX-8000C tableside consoles used with C-arm x-ray systems. The tableside console printed circuit board (PWB) may require replacement.
The affected units were distributed nationwide to medical facilities in New York, Colorado, Illinois, California, Maryland, Minnesota, and Washington. The impacted serial numbers include BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, and SWC2262003.
The console may not function properly, potentially causing delays in x-ray procedures. However, operations can continue using the operators console, manual switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop mechanism, which all remain fully operational.
The recalled product
- Product
- INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 12
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 (10)
- UDI-DI: 04987670100192. INFX-8000C
- Serial Numbers: BHA1992001
- BHB2132003
- SWC2242002
- AFB1832003
- SUC2262008
- SUC2292010
- BFB1972004
- SUB2172002
- SWC2262003
Distribution
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