FDAMay 18, 2020device
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 2042084-001-053034 2042084-001-215...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.
What to do
FDA enforcement status: Ongoing
Brands named
ge healthcare
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.2026-03-24
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