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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.
Manufacturer
Esaote Biomedica S.P.A.
1 Event
Recall of Device Recall Formula for Archimed
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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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