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CARESCAPE B850

GE Healthcare Finland Oy · Model MBC323 · UDI-DI 00840682146142

CBR MUD CBS BZK NHQ DSJ DQA DXG KOI NHO DXN MLD DSI BZQ CCK KRB QEM DQK DPS ORT OLW CCL CAP BZL DSK GWQ FLL MHX NHP DRT OMC CBQ OLT DPZ GWJ

510(k) clearances

Adverse events

Recalls

Facilities

Description

CARESCAPE B850 MBC323 (ATO MODEL)

Recalls

Date	Firm	Reason
2014-06-18	Spacelabs Healthcare Inc	With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
2011-06-08	Spacelabs Healthcare, Llc	Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to o
2007-10-08	Spacelabs Healthcare, Incorporated	Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.