Z-0018-05

Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm)

Name: Z-0018-05 Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm)
Creator: Datascope Corp
Published: 2004-09-24
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2004-09-24 / Terminated / root cause: software

FDA source

Datascope Corp began a recall of Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm) on 2004-09-24. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0018-05
Status: Terminated
Initiated: 2004-09-24
Posted: 2004-10-13
Terminated: 2005-09-15
Recalling firm: Datascope Corp.
Product: Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
Product code: NWI Electrosurgical Electrode Kit
Reason for recall: 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.
Root cause tag: software
FDA root cause: Other
Action: Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.
Quantity in commerce: 19
Distribution: Shipments made to three locations. These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC.
Product codes and lots: 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.

Product code NWI

K032338Class IITrio Monitor Model 0998-00-0600Datascope Corp. / cleared 2004-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)