Controversies

Edan Instruments Recalls Monitor IBP Cable After High Invasive Blood Pressure Readings

When the IBP cable (B.Braun interface), an accessory of Edan Instruments patient monitors, was used with B.Braun blood pressure sensors, invasive blood pressure measurements were high; the company reported to the Guangdong Provincial Medical Products Administration and implemented a Class III voluntary recall. Edan had previously also carried out recalls because fetal/maternal monitors lacked waterproof rating labels and a transcranial Doppler blood flow analyzer had an incorrect registration certificate number, among other issues. Progress: official recall. Entity involved: Edan Instruments, Inc. Scope: medical device recall.