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GE OEC Medical Systems, Inc FDA Recalls
11 recalls on file across devices, 0 of them Class I and 9 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is deClass IINov 21, 2024Due to manufacturing issue of insufficient sealing of X-ray |
| OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluorosClass IINov 21, 2024Due to manufacturing issue of insufficient sealing of X-ray |
| OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging syClass IINov 21, 2024Due to manufacturing issue of insufficient sealing of X-ray |
| OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provideClass IINov 21, 2024Due to manufacturing issue of insufficient sealing of X-ray |
| OEC 9800 Systems with 9-inch Image IntensifierClass IIMay 15, 2023Image intensifiers on systems, used to provide fluoroscopic/ |
| OEC 9900 Systems with 9-inch Image IntensifierClass IIMay 15, 2023Image intensifiers on systems, used to provide fluoroscopic/ |
| OEC Elite Systems with 9-inch Image IntensifierClass IIMay 15, 2023Image intensifiers on systems, used to provide fluoroscopic/ |
| OEC Flexiview 8800 Systems with 9-inch Image IntensifierClass IIMay 15, 2023Image intensifiers on systems, used to provide fluoroscopic/ |
| Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N Class IIMay 15, 2023Image intensifiers on systems, used to provide fluoroscopic/ |
| OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic anClass IIJun 10, 2021There is a potential that the coin cell battery used to moni |
| OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy,Class IIJun 10, 2021There is a potential that the coin cell battery used to moni |