Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application

During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.

An Urgent Medical Device Correction notification letter dated 11/25/19 was sent to customers. How will the corrective action be implemented and what is the efficiency of the corrective actions? To verify that your system is not affected by this problem, a visual inspection will be carried out by trained service staff. If no crack is found during the visual inspection, the C-arm can be used again in its original functionality in patient operation. Should a non-conformity be found and require repair, your device will be sent to the manufacturer and an equivalent loan device will be provided to you at no cost for the duration of the necessary repairs. Following the repair, the C-arm can be used again in its original functionality. Our service organization will contact you shortly to arrange a date to perform this corrective action. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. We thank you for your cooperation, and request that you promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Please ensure that this safety advisory is retained in your product related records appropriately. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. We would also request you to inform us of the identity of the device's new owner where possible. Please forward this safety information to any other organizations that could be affected by this measure.