HIGH

GE Healthcare Recalls Carescape Central Station Due to Reboot Risk

GE Healthcare recalled 173 units of the Carescape Central Station on September 5, 2025. The device may enter a continuous reboot cycle, risking loss of patient monitoring. This issue occurs when 118 to 120 stations connect to the network.

Quick Facts at a Glance

Recall Date
September 5, 2025
Hazard Level
HIGH
Brand
Wipro GE Healthcare Private
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Wipro GE Healthcare Private Ltd. or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop, software version V3.0.5, part number 5867474-04. It was distributed worldwide.

The Hazard

The device may enter a continuous reboot cycle, leading to loss of central patient monitoring. This risk arises only when 118 to 120 Carescape Central Stations are connected to the network.

Reported Incidents

No specific incidents or injuries have been reported related to this issue as of the recall date. The risk remains high due to the potential for loss of monitoring.

What to Do

Healthcare providers and patients should stop using the device immediately. Follow the manufacturer's recall instructions and contact Wipro GE Healthcare for further guidance.

Contact Information

For assistance, contact Wipro GE Healthcare Private Ltd. or your healthcare provider. More details are available on the FDA's recall page.

Key Facts

  • 173 units recalled
  • Class II recall due to potential risk
  • Contact Wipro GE Healthcare for instructions
  • Issue affects specific network configurations

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
GTIN 00195278343512
Serial Numbers: STU25210418SA
STU25210417SA
STU25210419SA
STU25250440SA
+15 more
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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