The Recall Desk
HighFDA (Devices)·Z-1265-2022·Announced 2022-06-22

GE CARESCAPE Central Station power supply failure recall

GE Healthcare is recalling CARESCAPE Central Station V2 patient monitoring devices due to potential power supply failure that can cause device shutdown and loss of patient monitoring.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with a critical failure mode: power supply component failure can cause device shutdown and loss of patient monitoring function. No illnesses, injuries, or hospitalizations have been reported, which places this at the High severity level rather than Severe.

Plain-English summary

GE Healthcare, LLC is recalling CARESCAPE Central Station (CSCS) V2 patient monitoring devices. The affected models include 2082278-001 (MA1700 Integrated) and 2082279-001 (MAS700 Desktop), along with specified replacement parts and display components including power supplies, CPU assemblies, and display units.

Approximately 30,993 central stations and 2,180 field replaceable units and displays are affected by this recall. A potential failure in the power supply component can cause the device to shut down, resulting in loss of patient monitoring at the central station.

The affected devices were distributed worldwide to healthcare facilities throughout the United States and to numerous countries and regions including Canada, Australia, United Kingdom, France, Germany, Japan, China, and many others across multiple continents.

The recalled product

Product
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 ASSE
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Patient Monitoring Equipment
Hazard
  • power-supply-failure
  • shutdown
  • monitoring-loss

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category