International Medical Devices Database

Manufacturer Address
Esaote Biomedica S.P.A., c/o The Anson Group, 7992 Castleway Drive, Indianapolis IN 46250-1943
Source
USFDA
4 Events

4 devices in the database

Device Recall Formul

Model / Serial
Serial numbers 157 and 158.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.
Product Description
Esaote brand Formul@ ECG System; part 9704220000.

Device Recall ArchiWin Colour

Model / Serial
Serial number 149.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.
Product Description
Esaote brand ArchiWin Colour ECG System; part 9704325000.

Device Recall Formula for Archimed

Model / Serial
Serial numbers: 103, 106, 107, 108, 129, 135, 136, 197, 205, 242, 270, 348, 361, 373, 420, 441, 462, 464, 520 and 522.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.
Product Description
Esaote brand Formula for Archimed ECG System; part 9704220000.

Device Recall Archimed 4220

Model / Serial
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.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.
Product Description
Esaote brand Archimed 4220 ECG System; part 9704220000.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Esaote Biomedica S.P.A.

4 devices in the database

Device Recall Formul

Device Recall ArchiWin Colour

Device Recall Formula for Archimed

Device Recall Archimed 4220