GE Healthcare, LLC 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 2042084-001-215165 2042084-001-079462 2042084-001-047389 2042084-001-112198 2042084-001-041673 2042084-001-227238 2042084-001-071564 2042084-001-503824 2042084-001-119839 2042084-001-569269 2042084-001-041674 2042084-0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 2042084-001-053034 2042084-001-215165 2042084-001-079462 2042084-001-047389 2042084-001-112198 2042084-001-041673 2042084-001-227238 2042084-001-071564 2042084-001-503824 2042084-001-119839 2042084-001-569269 2042084-001-041674 2042084-0
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
All Model Numbers that contain software versions 2.6 or 2.7
Products Sold
All Model Numbers that contain software versions 2.6 or 2.7
GE Healthcare, LLC is recalling CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLA due to The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detect. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm notified its consignees by letter on 05/18/2020. The letter explained the issue, how it occurs, cautions and a workaround. The notices were disseminated to the following entities: Director of Biomedical/Clinical Engineering, Chief of Nursing, Health Care Administrator/Risk Manager.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026