Health Canada — Medical Devices · Canada · 2018-08-31 · Type II
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Reported risk: AGFA has been notified by the manufacturer of their DX-D 600 device that one incident occurred on a similar dr device. The incident was caused by the breakage of the two steel cables that support the equipment to its roof anchor. To their knowledge this was the first occurrence of such an incident. Due to this, part of the equipment might fall down and can potentially harm the patient, user or third parties. This problem could occur in the most unfavorable case of excessive wear of the vertical pulley in the column.
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