Company: Datascope Corp
Date 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; MC02148-I3; MC02321-K3; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3.

RECALLING FIRM/MANUFACTURER
Datascope Corp., Mahwah, NJ, by letter on September 24, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
19 units.

DISTRIBUTION
CA, IN and SC.