Medtronic Recalls 0-arm 1000 Imaging Systems Due to Charger Board Defect
Medtronic is recalling 832 0-arm 1000 Imaging Systems worldwide because a defective charger board prevents batteries from fully recharging, rendering the system inoperable.
What this means for you
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: The recall is classified as FDA Class II. The hazard is a functional failure (inability to operate) rather than a direct physical injury or death, fitting the criteria for a moderate severity recall involving a significant defect without reported harm.
Plain-English summary
Medtronic Navigation, Inc. is recalling 832 units of the 0-arm 1000 Imaging System, including models Bl-700-00027-XXX and B1-700-00028-XXX. The recall covers systems distributed worldwide, including the United States and numerous foreign countries. The affected serial numbers are listed in the official recall documentation.
The recall is due to a defect in the charger board. If the charger board is not functioning properly, the system's batteries will not receive a full recharge of their potential capacity. This results in the inability of the system to take X-rays, open the gantry, or move the system from one place to another. This malfunction may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced.
The 0-arm 1000 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging. It is intended to be used where a physician benefits from 2D and 3D information of anatomical structures and objects with high x-ray attenuation, such as bony anatomy and metallic objects. The system is compatible with certain Image Guided Surgery Systems. Users should contact Medtronic Navigation for instructions on replacing the charger board and/or batteries.
The recalled product
- Product
- Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !D
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Category
- Medical Device — Imaging System
- Affected units
- 832
Distribution
Distributed nationwide across the United States.
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