Medical Device Alerts issued in June 2019
An alert was issued about Dialog+ haemodialysis machines.
In this monthly update, we highlight selected Medical Device Alerts that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.
Dialog+ haemodialysis machines with software versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) – software and hardware upgrade required (MDA/2019/024). Issued 26 June 2019. Manufactured by B. Braun Avitum AG – Malfunction of the temperature sensor can result in temperature of the dialysis fluid to be more than ±1°C outside the programmed values, which can lead to inadequate treatment.
Article citation: Drug Safety Update volume 12, issue 12: July 2019: 5.