Recall Z-2750-2020 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
| Date | Aug 4, 2020 (initiated Jun 22, 2020) |
| Status | Terminated |
| Reason | CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor. |
| Root cause | Software Design Change |
| Action | You can continue to use your CARESCAPE ONE to monitor patients. Follow the instructions below each time the CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor. 1. As per the User Manual, closely observe and monitor the patients clinical condition and ECG waveforms on the CARESCAPE B450/B650/B850 host monitor for V Fib during the Learning phase and for several minutes after the Learning phase to allow the algorithm to reach optimal detection performance. 2. As per the User Manual, if the Learning message on the host monitor does not clear after 30 seconds, select the Relearn QRS |
| Quantity | 8,414 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of MT, NC, TX and WI. The countries of Australia, Austria, Bahrain,Belgium, Bolivia, Brazil ,Canada, Chile, Check Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES GE Healthcare, Mar 29, 2020 |