Recall Z-0534-04 ยท DPS Electrocardiograph
Esaote Biomedica S.P.A.
Esaote brand ArchiWin Colour ECG System; part 9704325000.
| Date | Jul 20, 2004 (initiated Dec 23, 2003) |
| Status | Terminated |
| Reason | If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient. |
| 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 | 1 |
| Distribution | California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.