FDA recall Z-0213-2026

Wipro GE Healthcare Private Ltd. · Class II · device

Product

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube

Reason for recall

GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.

Distribution

Worldwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-09-05
Report date: 2025-10-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bengaluru, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0213-2026