Z-0535-04

Esaote brand Formul@ ECG System; part 9704220000

Name: Z-0535-04 Esaote brand Formul@ ECG System; part 9704220000
Creator: Esaote Biomedica S.P.A.
Published: 2003-12-23
License: https://open.fda.gov/license/

Esaote Biomedica SpA / initiated 2003-12-23 / Terminated

FDA source

Esaote Biomedica S.P.A. began a recall of Esaote brand Formul@ ECG System; part 9704220000 on 2003-12-23. The reason FDA records is "If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0535-04
Status: Terminated
Initiated: 2003-12-23
Posted: 2004-07-20
Terminated: 2004-10-28
Recalling firm: Esaote Biomedica SpA
Product: Esaote brand Formul@ ECG System; part 9704220000.
Product code: DPS Electrocardiograph
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.
FDA root cause: Other
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.
Quantity in commerce: 2
Distribution: California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.
Product codes and lots: Serial numbers 157 and 158.

Product code DPS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)