Central stations recalled over reboot loop that halts patient monitoring
GE HealthCare is recalling 173 Carescape Central Stations running software V3.0.5 because the system can enter a continuous reboot cycle, losing central monitoring of connected patients.
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: Scored 3 under the risk-of-harm criterion: a loss of central patient monitoring is a stated clinical risk, and no injuries are reported.
Plain-English summary
The GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, part number 5867474-04, is being recalled.
GE HealthCare has identified an issue that can cause the system to enter a continuous reboot cycle. If that occurs, a loss of central monitoring of connected patients could result. The firm states the issue occurs only when the number of central stations connected to the network is 118, 119 or 120.
The recall covers 173 units carrying GTIN 00195278343512, with serial numbers including STU25210418SA, STU25210417SA, STU25210419SA and STU25250440SA, distributed worldwide. The FDA has classified the action as Class II.
The enforcement record describes the reboot condition and reports no injuries. Sites running version V3.0.5 should follow GE HealthCare's instructions.
The recalled product
- 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
- Manufacturer
- Wipro GE Healthcare Private Ltd.
- Hazard
- software-defect
- reboot-loop
- loss-of-monitoring
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 00195278343512
- Serial Numbers: STU25210418SA
- STU25210417SA
- STU25210419SA
- STU25250440SA
- STU25250439SA
- STU25260447SA
- STU25210407SA
- STU25210406SA
- STU24200003SA
- STU24200006SA
- STU24200005SA
- STU24200004SA
- STU23240015SA
- STU24240019SA
- STU24240020SA
- STU24240007SA
- STU24240022SA
- STU24240021SA
- STU24330020SA
Distribution
Distribution scope not specified by the agency.
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