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Devices
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.
Manufacturer
Esaote Biomedica S.P.A.
1 Event
Recall of Device Recall Archimed 4220
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Manufacturer
Esaote Biomedica S.P.A.
Manufacturer Address
Esaote Biomedica S.P.A., c/o The Anson Group, 7992 Castleway Drive, Indianapolis IN 46250-1943
Source
USFDA
Language
English
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