求翻译：4.1因顾客投诉、产品留样观察或国家抽查，发现已出厂的产品存在不合格，或已售出的医疗器械未能达到预期用途及由于某种质量缺陷怀疑产品可能对病人造成伤害或潜在的伤害或违背法规要求，应向使用者发布忠告性通知和召回产品，并按《不合格品控制程序》处理。如出现重大质量问题时，应及时向当地食品药品监督管理部门报告。是什么意思？

4.1 observation due to customer complaints, product samples or national checks found the factory's products is not eligible or medical devices were sold failed to meet the intended uses and, for some quality defects of suspected products may cause damage or potential damage to the patient or in brea