CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850… — Class II medical device recall Z-1567-2013
Terminated recall by GE Healthcare, LLC, reported 2013-07-03, distributed nationwide. GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues incl
| Recall number | Z-1567-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-07-20 |
| Classified | 2013-06-21 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2014-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, HK, IL, IN, IQ, IT, JP, KR, KW, LB, LT, MT, MX, MY, NO, NZ, PA, PE, PL, PT, QA, SA, SE, SG, SI, SK, TH, TN, TR, TW, UY, ZA |
| Quantity | 12,779 |
| Serial numbers | SED010464924GA, SED010485111GA, SED010485115GA, SED010485117GA, SED010485118GA, SED010485119GA, SED010485122GA, SED010485123GA, SED010485124GA, SED010485125GA, SED010485126GA, SED010485130GA, SED010485131GA, SED010485135GA, SED010485136GA, SED010485137GA, SED08400200GP, SED09090248GP, SED09130299GP, SED09130301GP, SED09130304GP, SED09130306GP, SED09130308GP, SED09130309GP, SED09130310GP and 475 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1567-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.