FDA Device recall Z-2256-2013
GE Healthcare, CARESCAPE Monitor B650
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of GE Healthcare, CARESCAPE Monitor B650 by Ge Healthcare, citing GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2256-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-12 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.
Reason
GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.
Identifiers
| code_info | Parent SN SEW10233202HA SEW10233203HA SEW10233204HA SEW10233206HA SEW10233209HA SEW10233210HA SEW10243447HA SEW…Parent SN SEW10233202HA SEW10233203HA SEW10233204HA SEW10233206HA SEW10233209HA SEW10233210HA SEW10243447HA SEW10243449HA SEW10243450HA SEW10243458HA SEW10243476HA SEW10243477HA SEW10243478HA SEW10243479HA SEW10243481HA SEW10243482HA SEW10243484HA SEW10243486HA SEW10243487HA SEW10243489HA SEW10243490HA SEW10243491HA SEW10243492HA SEW10243496HA SEW10243498HA SEW10243499HA SEW10243500HA SEW10243503HA SEW10243504HA SEW10354687HA SEW10354688HA SEW10354694HA SEW10354695HA SEW10354696HA SEW10354697HA SEW10354701HA SEW10354704HA SEW10354706HA SEW10354707HA SEW10354708HA SEW10354709HA SEW10354712HA SEW10354713HA SEW10354717HA SEW10354722HA SEW10354724HA SEW10354728HA SEW10354730HA SEW10354736HA SEW10354738HA SEW10354740HA SEW10354741HA SEW10354746HA SEW10354749HA SEW10354751HA SEW10354752HA SEW10354754HA SEW10354756HA SEW10354757HA SEW10354758HA SEW10354759HA SEW10354760HA SEW10354761HA SEW10354762HA SEW10354763HA SEW10354764HA |
|---|
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-2256-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.