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Terminated

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

FDA Recall Z-0018-05 · Posted 2004-10-13

Recalling FirmDatascope Corp
Recall StatusTerminated
Product CodeNWI
Date Initiated2004-09-24
Date Terminated2005-09-15
Product Quantity19

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.

Firm Action

Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.

Root Cause

Other

Distribution Pattern

Shipments made to three locations. These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032338TRIO MONITOR MODEL 0998-00-0600Datascope Corp. · 2004-02-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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