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Devices
Device Recall Agfa IMPAX CardioVascular Suite Results Management
Model / Serial
Software Versions: 2.04.17, 2.04.19 and 2.04.20.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide to five hospitals in DC, NY, OH, TN, and VA.
Product Description
Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI
Manufacturer
AGFA Corp.
1 Event
Recall of Device Recall Agfa IMPAX CardioVascular Suite Results Management
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Manufacturer
AGFA Corp.
Manufacturer Address
AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
Source
USFDA
Language
English
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