HIGH

GE Healthcare Recalls Carescape Central Station Over Reboot Risk

GE Healthcare recalled 2,306 Carescape Central Station devices on September 5, 2025, due to a software issue. The problem can cause a continuous reboot cycle, risking loss of patient monitoring. The recall affects devices with software version V3.0.5 when connected in specific network conditions.

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 recall involves the GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03. These units were distributed worldwide.

The Hazard

A continuous reboot cycle may occur when 118 to 120 central stations connect to the network. This can lead to a loss of central monitoring of patients, posing a significant risk in healthcare settings.

Reported Incidents

No specific incidents or injuries have been reported. Nonetheless, the risk of losing patient monitoring is significant.

What to Do

Stop using the Carescape Central Station immediately. Follow the manufacturer’s instructions for the recall and contact Wipro GE Healthcare Private Ltd. or your healthcare provider for further actions.

Contact Information

For assistance, call Wipro GE Healthcare Private Ltd. or visit their website. More details are available at the FDA recall notice.

Key Facts

  • Recall date: September 5, 2025
  • Quantity recalled: 2,306 units
  • Software version affected: V3.0.5
  • Notification method: Letter

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
GTIN 00195278343383
Serial Numbers: STV25225456SA
STV25225455SA
STV25266464SA
STV25235817SA
+15 more
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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