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October 20, 2004
Company: Datascope CorpDate of Enforcement Report: 10/20/04 Class: II PRODUCT Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Recall # Z-0018-05. REASON Software anomaly where the variable heart rates may be displayed inaccurately or intermittent “dashes” may be displayed when the patient’s heart rate is derived from ECG. CODE Serial Number: MC02017-I3; MC02134-I3; MC02138-I3;...
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