Esaote Biomedica S.P.A. c/o The Anson Group Esaote brand ArchiWin Colour ECG System; part 9704325000. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Esaote brand ArchiWin Colour ECG System; part 9704325000.
Brand
Esaote Biomedica S.P.A. c/o The Anson Group
Lot Codes / Batch Numbers
Serial number 149.
Products Sold
Serial number 149.
Esaote Biomedica S.P.A. c/o The Anson Group is recalling Esaote brand ArchiWin Colour ECG System; part 9704325000. due to If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, KY
Page updated: Jan 10, 2026