FDA recall Z-3143-2026

GE Medical Systems Information Technologies Inc · Class II · device

Product

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

Reason for recall

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2026-07-30
Report date: 2026-09-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3143-2026