Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult
Check against the official notice below — it lists the full affected range.
Draeger Medical Systems, Inc. is recalling its Infinity Acute Care System (IACS) Monitoring Solution due to a software anomaly that causes the loss of patient settings and stored patient data. The affected devices include multiple catalog numbers (MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818) and have been distributed worldwide, including throughout the United States and numerous countries in Europe, Asia, Africa, and the Americas. A total of 25,629 units are involved in this recall.
The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Software anomaly resulting in the loss of patient settings and stored patient data.
Reason for recall: Software anomaly resulting in the loss of patient settings and stored patient data. Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czech Republic Denmark Egypt Finland France Germany Ghana Greece Hong Kong Hungary India Indonesia Ireland Italy Japan Jordan Kenya Kuwait Latvia Liechtenstein Lithuania Macedonia Malaysia Maldives Quantity: 25, 629 Lot/code info: Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818 UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.