CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor an
FDA device recall Z-2750-2020 · posted 2020-08-04 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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.
- Action taken
- 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 option from the ECG menu on the host monitor following these steps. Select the HR parameter window. Select Advanced > Page 1. Select Relearn QRS. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. After the CARESCAPE ONE Monitor has been updated, discontinue usage of any previous versions of CARESCAPE ONE software. Destroy any software media containing previous versions of CARESCAPE ONE software, including reimage, upgrade kits, and FRUs. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 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,
- Date initiated
- 2020-06-22
- Date posted
- 2020-08-04
- Date terminated
- 2024-08-19
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES (K200494) | GE Healthcare | 2020-03-29 |