GE Healthcare Recalls CARESCAPE Patient Data Modules Due to False Alarms
GE Healthcare is recalling CARESCAPE Patient Data Modules because they may display false flat-line ECGs and asystole alarms when used with an AED.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical monitor) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling the CARESCAPE Patient Data Module (PDM) used with CARESCAPE B450/B650/B850, SOLAR 8000M/I, and Transport Pro monitors. The recall affects 89,109 units distributed worldwide that contain software versions 2.6 or 2.7.
The recall is due to a software defect where the PDM may issue a false flat-line ECG waveform and display an asystole alarm if an Automated External Defibrillator (AED) is used to perform defibrillation while pace detection is turned on. This can result in incorrect patient status displays on the monitor.
Healthcare facilities and users should check their inventory for affected model numbers and software versions. GE Healthcare is providing instructions for the necessary corrective actions to resolve the issue.
The recalled product
- Product
- CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 89,109
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 (1)
- All Model Numbers that contain software versions 2.6 or 2.7
Distribution
Distribution scope not specified by the agency.
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