CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transp
FDA device recall Z-2424-2020 · posted 2020-06-24 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- 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.
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 89,109 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2020-05-18
- Date posted
- 2020-06-24
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (K071073) | Ge Medical Systems Information Technologies | 2007-05-11 |