FDA Device recall Z-1567-2013
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in mu…
- FDA Device
- Class II
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class II recall of CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in mu… by Ge Healthcare, citing GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unsta….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1567-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-20 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. It is a stand-alone monitor or interfaced to other devices. is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.
Reason
GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.
Identifiers
| code_info | Mfg Lot or Serial # SED11107648GA SED11107652GA SED11117927GA SED11117959GA SED11168563GA SED10293123GA SED10293…Mfg Lot or Serial # SED11107648GA SED11107652GA SED11117927GA SED11117959GA SED11168563GA SED10293123GA SED10293124GA SED10353742GA SED10353743GA SED10132473GA SED10303335GA SED10333640GA SED11178619GA SED10142532GA SED10485114GA SED09340621GA SED09340629GA SED09340640GA SED09340654GA SED09340655GA SED09471473GA SED10021715GA SED10021720GA SED10041824GA SED10112150GA SED10112155GA SED10112156GA SED10112165GA SED10112173GA SED10112199GA SED10122287GA SED10122288GA SED10122291GA SED10122297GA SED10122314GA SED10122331GA SED10122332GA SED10122334GA SED10122335GA SED09090248GP SED09130299GP SED09130301GP SED09130304GP SED09130308GP SED09130309GP SED09130310GP SED09130313GP SED09491635GA SED10505510GA SED11067055GA SED11077158GA SED11077165GA SED11087325GA SED11087333GA SED11087361GA SED11097434GA SED11097448GA SED11097449GA SED11097455GA SED11097498GA SED11097532GA SED11097536GA SED11097543GA SED11097546GA SED11097547GA SED1 |
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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-1567-2013%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.