# FDA recall Z-2424-2020

> **GE Healthcare, LLC** · Class II · device recall initiated 2020-05-18.

## 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  2042084-001-047549  2042084-001-514651  2042084-001-163572  2042084-001-583721  2042084-001-427592  2042084-001-527358  2042084-001-583723  2042084-001-317166  2042084-001-583724  2042084-001-583715  2042084-001-583718  2042084-001-055156  2042084-001-583722  2042084-001-041835  2042084-001-074124  2042084-001-583706  2042084-001-583707  2042084-001-519926  2042084-001-583717  2042084-001-583713  2042084-001-207863  2042084-001-460604  2042084-001-079192  2042084-001-197663  2042084-0

## Reason for recall

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.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-2424-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-05-18
- **Report date:** 2020-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2424-2020

## Citation

> AI Analytics. FDA recall Z-2424-2020. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-2424-2020. Source: US FDA. Licensed CC0.

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