Datascope Corp Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
Brand
Datascope Corp
Lot Codes / Batch Numbers
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.
Products Sold
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.
Datascope Corp is recalling Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). due to Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, SC
Page updated: Jan 10, 2026