| 2024-11-21 |
Class II
|
Ongoing |
Z-0706-2025 |
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoros… |
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Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0705-2025 |
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is de… |
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Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0704-2025 |
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide… |
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Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2024-11-21 |
Class II
|
Ongoing |
Z-0703-2025 |
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging sy… |
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Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2279-2023 |
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N … |
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Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, wh… |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2278-2023 |
OEC Elite Systems with 9-inch Image Intensifier |
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Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, wh… |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2277-2023 |
OEC 9900 Systems with 9-inch Image Intensifier |
— |
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, wh… |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2276-2023 |
OEC 9800 Systems with 9-inch Image Intensifier |
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Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, wh… |
| 2023-05-15 |
Class II
|
Ongoing |
Z-2275-2023 |
OEC Flexiview 8800 Systems with 9-inch Image Intensifier |
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Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, wh… |
| 2021-06-10 |
Class II
|
Terminated |
Z-2161-2021 |
OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy,… |
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There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. |
| 2021-06-10 |
Class II
|
Terminated |
Z-2160-2021 |
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic an… |
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There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. |