The Recall Desk
HighFDA (Devices)·Z-0214-2026·Announced 2025-10-29

[pending] GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part

Pending LLM rewrite. Source: FDA_DEVICE Z-0214-2026.

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: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube
Manufacturer
Wipro GE Healthcare Private Ltd.
Category
Medical Device — Devices

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 (20)

  • GTIN 00195278343383
  • Serial Numbers: STV25225456SA
  • STV25225455SA
  • STV25266464SA
  • STV25235817SA
  • STV25235816SA
  • STV25286682SA
  • STV25225594SA
  • STV25235792SA
  • STV25235774SA
  • STV25225550SA
  • STV25235626SA
  • STV25235625SA
  • STV25184592SA
  • STV25235628SA
  • STV25235631SA
  • STV25184595SA
  • STV25235629SA
  • STV25235632SA
  • STV25235630SA

Distribution

Distribution scope not specified by the agency.

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