China NMPA Product Recall - Anesthesia system

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a Class II voluntary recall on July 16, 2015, for its Fabius MRI Anesthesia System. This action, reported to the National Medical Products Administration (NMPA), stemmed from incidents where the anesthesia system or its components were attracted by strong magnetic fields exceeding 40 millitesla, specifically when the device was being moved or placed in a non-use state. This magnetic attraction could cause parts of the anesthesia machine to loosen, posing a risk of personal injury. The primary issue identified was an insufficient clarity in the original instruction manuals and device labels, which specified magnetic field limits for operational use but failed to explicitly detail precautions for non-use conditions. To mitigate this safety concern, Dräger implemented several corrective actions. These included revising the instruction manuals to incorporate clear precautions and warnings regarding magnetic field strength during non-use. Furthermore, the company committed to installing an additional door lock, free of charge, to enhance the existing ventilator door locking mechanism on affected units. Safety notices and supplementary instructions were issued to customers globally, with 5 units sold and 4 imported into China being specifically affected by these measures.