Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient m
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 across multiple catalog numbers (MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818). The recall affects approximately 28,317 total products that were distributed worldwide, including throughout the United States and numerous international markets. The hazard involves a failure of the invasive pressure visual and audible alarms to activate when needed.
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.
The invasive pressure visual and audible alarms may not activate.
Reason for recall: The invasive pressure visual and audible alarms may not activate. Distribution: Worldwide Distribution - USA (nationwide) and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Liech Quantity: 28317 total products Lot/code info: Catalog Number(s): MS18841, MS20401, MS20407, 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.