Alphenix INFX-8000H systems recalled over ceiling suspension screws that loosen
Canon Medical Systems is recalling 3 units of the Alphenix INFX-8000H because fixing screws of the ceiling movement gear in the ceiling suspended arm may become loose.
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: Scored 2 because the record's stated consequences are loss of movement, noise and a sensor error, with no patient harm or reported injury.
Plain-English summary
The Alphenix INFX-8000H interventional fluoroscopic x-ray system is being recalled by Canon Medical System, USA, INC.
The record states it has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. The record states that as a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed.
The record lists 3 units under serial numbers D2A1672385, A2A20Z2165 and B2A1692426. Distribution was worldwide, covering the United States nationwide and the Dominican Republic. The FDA has classified the action as Class II.
The stated consequences in the enforcement record are loss of lateral movement, abnormal noise and a sensor error, and no injuries are reported. Facilities should follow Canon's instructions.
The recalled product
- Product
- Alphenix INFX-8000H, interventional fluoroscopic x-ray system
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — Fluoroscopy
- Affected units
- 3
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 (3)
- serial numbers: D2A1672385
- A2A20Z2165
- B2A1692426.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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