GE OEC recalls Elite Systems with 9-inch Image Intensifier due to risk of detachment during movement, potentially causing injuries like fractures and bruising. Affected units have specific serial numbers listed in the recall.
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
GE OEC is recalling Elite Systems with 9-inch Image Intensifier models that can detach if moved violently, potentially causing injuries such as fractures, bruising, or pain. Users should stop using these systems immediately to avoid injury.
The image intensifier component can become detached if the system experiences a large impact force during movement. This detachment could cause the component to fall and result in injuries such as fractures, bruising, or pain.
Medical professionals using GE OEC Elite Systems with 9-inch Image Intensifier for imaging procedures are most at risk if the system is moved violently. The recall affects specific models with listed serial numbers.
Check if your GE OEC Elite System has a 9-inch Image Intensifier and one of the listed serial numbers (e.g., FSXXTX00180, FSXXXX00020, etc.).
Immediately stop using the affected GE OEC Elite Systems with 9-inch Image Intensifier to prevent potential injury from detached components.
The recall affects GE OEC Elite Systems with 9-inch Image Intensifier models with specific serial numbers listed in the record, such as FSXXTX00180, FSXXXX00020, and others.
Check your system's serial number against the list of affected serial numbers provided in the recall notice.
The recall states that detached components could cause injuries such as fractures, hematoma, contusion, bruise, or pain.
We’ve drafted a message you can send GE OEC to request your refund or repair — edit it as you like.
Subject: Recall Z-2278-2023 — GE OEC GE OEC Hello, I own a GE OEC that is covered by recall Z-2278-2023 from GE OEC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.