Oct

2004

Datascope Corp Class II

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Datascope Corp Class II

Amy Sellers

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