FDA-Device2026-09-23Class IIPROCESSING DEFECT
GE Carescape Central Station CSCS V3 recalled for patient monitoring delay after restart
What this means
GE's Carescape Central Station patient monitoring system may take up to 3 minutes to resume monitoring after a restart. During this gap, clinically important changes in a patient's condition might not be detected right away.
- If you operate this device, contact GE Medical Systems for guidance on the issue and any available updates.
- Be aware of the potential 3-minute monitoring gap after system restarts and plan accordingly in your workflow.
The agency's original wording
Hazard
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
29,570 (23,632 US; 5,938 OUS)
Manufactured in
3114 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3143-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.