Philips Zenition 50 and Zenition 70 Mobile C-Arm Systems are being recalled due to a potential hardware failure where a fuse on the Mains Control Unit board may blow. This issue can occur while the system is starting up or during an active medical procedure, affecting 3,233 units (986 Zenition 50 and 2,247 Zenition 70 units). If the fuse blows, the system will lose power and shut down, which could interrupt surgical or diagnostic procedures. No injuries or incidents have been reported in the provided documentation.
The Mains Control Unit board fuse can fail, causing an unexpected power loss during use. If this occurs during a medical procedure, the loss of imaging could lead to delays or complications for the patient.
Quantity: 986 units affected globally.
Quantity: 2,247 units affected globally.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES ยท Raw API Response
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