-
IntelePACS (Image Fusion Module)
An incorrect SUV (standard uptake value) calculation occurs in the PET/CT fusion viewer module. This issue only occurs on days with a DST (daylight savings time) change. The issue occurs because the calculation relies on a time calculation which does not correctly consider the DST change. An incorrect SUV may lead to an incorrect diagnosis.…
-
Hamilton C2 and C3 Intensive Care Ventilators
This field safety notice (FSN) provides an updated information on Hamilton medical ventilators Hamilton-C2/C3: Hamilton Medical AG became aware of a malfunction with our Hamilton-C2/C3 ventilators when used long term in neonatal patients. If an affected device Hamilton-C2 or Hamilton-C3 is used accumulatively for 91 days in neonatal patient without a restart of the device,…
-
MiniMed and Paradigm Insulin Pumps
When air pressure decreases (e.g., during flight takeoff), more insulin may be released than expected. Additionally, unintended insulin may be released even if the pump’s delivery is suspended or programmed to zero units per hour. When air pressure increases (e.g., during flight landing), less insulin may be released than expected. Recall Start Date: January 28,…
-
Heater-Cooler Unit HCU 40
The ice bracket is attached to the inlet of the cardioplegia tank where ice is produced. To avoid interrupting the water circulation on the cardioplegia side, ice must not cover the opening at the bottom of the tank. Due to its very high thermal conductivity, the ice bracket prevents ice buildup in the affected area…