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Terminated

Esaote brand Formul@ ECG System; part 9704220000.

FDA Recall Z-0535-04 · Posted 2004-07-20

Recalling FirmEsaote Biomedica S.P.A.
Recall StatusTerminated
Product CodeDPS
Date Initiated2003-12-23
Date Terminated2004-10-28
Product Quantity2

Reason for Recall

If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.

Firm Action

A recall letter dated December 23, 2003 was sent to distributors asking them for contact information for affected customers. Esaote will the provide the user customers with an addendum to the users manual until a software upgrade becomes available and is installed.

Root Cause

Other

Distribution Pattern

California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.

Official Source

View FDA Recall →

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

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