GE Healthcare CARESCAPE Central Station software recall for communication issues
GE Healthcare is recalling CARESCAPE Central Station software version 2.0.2 because units may experience unexpected network communication issues after boot-up or 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 3/5 (High).
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: The recall involves a medical device software defect that could disrupt patient monitoring and alarm systems. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Medical Systems Information Technologies, Inc. is recalling 1,803 units of CARESCAPE Central Station (CSCS) software version 2.0.2. The software is intended to collect and display physiological, patient demographic, and other non-medical information from a network, including alarm annunciation and printing capabilities.
The recall was initiated because the affected software units may experience unexpected "NO COMM" (No Communication) and network communication issues after boot-up or system restart. This defect could potentially disrupt the display of patient data or alarm notifications.
The affected units were distributed worldwide, including in the United States and numerous other countries. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the communication issues.
The recalled product
- Product
- GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information.…
- Affected units
- 1,803
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 (3)
- Model
- Catalogue
- or Code/ UDI/ Mfg. Lot or Serial Number Model
Distribution
Distributed nationwide across the United States.
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