Quick Facts at a Glance
- Recall Date
- September 5, 2025
- Hazard Level
- HIGH
- Brand
- GE Healthcare
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GE Healthcare
- Product type
- CSCS MAS800 Central Station Desktop
- Model numbers
- CSCS MAS800 Desktop, GTIN 00195278343512, Serial STU...SA
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 5, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The CSCS MAS800 Central Station is part of GE Healthcare’s Carescape monitoring suite. It aggregates patient data from connected monitors to provide real-time coverage in clinical settings.
Why This Is Dangerous
A software fault can force a reboot loop, potentially interrupting continuous patient monitoring across a network of central stations.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may experience outages in central monitoring if multiple CSCS units reboot, potentially affecting patient safety and response times.
Practical Guidance
How to identify if yours is affected
- Verify software version V3.0.5 on the device label
- Confirm Part Number 5867474-04
- Compare serial numbers against the recall list
- Determine whether 118-120 central stations are connected to your network
Where to find product info
Serial numbers are on label stickers; GTIN on packaging; software version on system splash screen or device UI
What timeline to expect
4-8 weeks for replacement or repair, depending on parts availability and service scheduling
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a formal incident report
- Consult FDA/recall supervisor if vendor remains unresponsive
How to prevent similar issues
- Maintain an up-to-date asset register for critical medical devices
- Verify software updates and test in a controlled environment before deployment
- Establish procedures to isolate and quarantine recalled devices
- Engage with OEM for timely remediation
Documentation advice
Save the recall letter, capture device label photos, keep serial numbers and network topology, log all communications with the manufacturer
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Product Details
Model: CSCS MAS800 Desktop. Software version: V3.0.5. Part Number: 5867474-04. GTIN: 00195278343512. Serial Numbers include STU25210418SA, STU25210417SA, STU25210419SA, STU25250440SA, STU25250439SA, STU25260447SA, STU25210407SA, STU25210406SA, STU24200003SA, STU24200006SA, STU24200005SA, STU24200004SA, STU23240015SA, STU24240019SA, STU24240020SA, STU24240007SA, STU24240022SA, STU24240021SA, STU24330020SA. Sold worldwide. Price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Software version V3.0.5
- Serial Numbers: 18 listed
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Safety Guide
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