CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling approximately 30,993 CARESCAPE Central Station (CSCS) V2 units and 2,180 related field replaceable units and display parts due to a potential power supply component failure. The affected devices include two models: the CSCS V2 MA1700 Integrated (Model #2082278-001) and the CSCS V2 MAS700 Desktop (Model #2082279-001). These devices have been distributed worldwide, including throughout the United States and numerous countries internationally.
The power supply component failure can cause the central station to shut down unexpectedly, potentially resulting in loss of patient monitoring capability at the central station. The recall affects all CARESCAPE Central Station V2 units regardless of manufacture date. The source document does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.
Reason for recall: The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. Distribution: Worldwide distribution - US Nationwide. There was also military/government distribution and the countries of Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Quantity: 30,993 Central Stations and 2,180 FRUs and displays Lot/code info: All CARESCAPE Central Station V2 units: (1) CSCS V2 MA1700 Integrated, Product Code SKN, Model #2082278-001, GTIN 00840682109666; (2) CSCS V2 MAS700 Desktop, Product Code SNF, Model #2082279-001, GTIN 00840682109604. NOTE: The Product Code is the first 3 letters of the serial number.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.