GE Carescape Central Station Recall for Monitoring Delay
GE Medical Systems is recalling Carescape Central Station units that may not resume patient monitoring for three minutes after a system restart.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall, and the hazard involves a delay in recognizing clinically significant events, which aligns with the criteria for Severe severity.
Plain-English summary
GE Medical Systems Information Technologies Inc is recalling Carescape Central Station CSCS V3 MAS800 Desktop and CSCS V3 MAI800 Integrated units. The recall involves 29,570 units distributed worldwide, including 23,632 in the United States and 5,938 outside the US.
The device may not resume patient monitoring for at least three minutes following a system restart. This issue can lead to a potential delay in the recognition of clinically significant events. The agency has classified this as a Class II recall.
Healthcare facilities should contact GE Medical Systems for instructions on how to address the issue. Consumers should not use the affected devices for patient monitoring until the issue is resolved.
The recalled product
- Product
- Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Hazard
Distribution
Distributed nationwide across the United States.
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