FDA Device recall Z-2114-2014
GE Healthcare, CARESCAPE Monitor B650
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of GE Healthcare, CARESCAPE Monitor B650 by Ge Healthcare, citing possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB h….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2114-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-07 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
Reason
Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor.
Identifiers
| code_info | Mfg Lot or Serial # System ID SEW10233202HA M1176021-052037 SEW10233203HA M1176021 SEW10233204HA M1176021-052037 SE…Mfg Lot or Serial # System ID SEW10233202HA M1176021-052037 SEW10233203HA M1176021 SEW10233204HA M1176021-052037 SEW10233206HA M1176021-052037 SEW10233209HA M1176021-052037 SEW10233210HA M1176021-052037 SEW10243447HA M1176021-052037 SEW10243449HA M1176021-052037 SEW10243450HA M1176021-052037 SEW10243458HA M1176021-052037 SEW10243476HA M1176021-052037 SEW10243477HA M1176021-052037 SEW10243478HA M1176021-052037 SEW10243479HA M1176021-052037 SEW10243481HA M1176021-052037 SEW10243482HA M1176021-052037 SEW10243484HA M1176021-052037 SEW10243486HA M1176021-052037 SEW10243487HA M1176021-052037 SEW10243489HA M1176021-052037 SEW10243490HA M1176021-052037 SEW10243491HA M1176021-052037 SEW10243492HA M1176021-052037 SEW10243496HA M1176021-052037 SEW10243499HA M1176021-052037 SEW10243500HA M1176021-052037 SEW10243503HA M1176021-052037 SEW10243504HA M1176021-052037 SEW10354687HA M1176021 SEW10354688HA M1176021 SEW10354694HA M1176021-052037 SEW10354695HA M1176021-052037 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2114-2014%22
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