Class 2 Device Recall Archimed 4220

• Date Initiated by Firm: December 23, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on October 28, 2004
• Recall Number: Z-0532-04
• Recall Event ID: 27980
• Product Classification: Electrocardiograph - Product Code DPS
• Product: Esaote brand Archimed 4220 ECG System; part 9704220000.
• Code Information: Serial numbers: 110, 124, 125, 128, 131, 137, 189, 258, 325, 513, 514, 521, 522, 523, 525, 696, 877, 835, 836, 837, 1089, 1090, 1091, 1096, 1138, 1419, 1466 and 1467.
• Recalling Firm/ Manufacturer: Esaote Biomedica S.P.A.; c/o The Anson Group; 7992 Castleway Drive; Indianapolis IN 46250-1943
• For Additional Information Contact: Colleen Hittle Densmore; 317-849-1916 Ext. 102
• Manufacturer 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 Determined 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: 28
• Distribution: California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.