Devices

Device Recall Cardio Review Station (CRS)

Model / Serial
Software versions - 2.01.B10, 2.01.B15, 2.01.B25, 2.02.B32, 2.02.B39 2.02.B40, 2.02.B43, 2.03.B16, 2.02.B23, 2.03.B26, 2.03B31.P01, 2.03.B31, 2.04.B03, 2.04.B06, 2.05.B01, 2.04.B07, 2.06.47, 2.06.47.02, 2.05.B02, 2.06.47.08, 2.06.47.08, 2.06.47.08.03, 2.06.47.02, 2.06.47.18, 2.06.47.18.01, 2.06.47.27, 2.06.47.18.02, 2.06.47.30, 2.06.47.37, 2.06.47.40, 2.07.24, 2.08.05.01, 2.07.30.01, 2.07.30.02, 2.05.03.04, 2.09.03, 2.07.30.07, 2.07.35, 2.07.24.SLEH.07, 2.09.04.02, 2.07.35.01, 2.10.06, 2.11.06, 2.05.04.05, 2.12.09, 2.13.08, 2.13.08.SU1, 2.14.03, 2.14.03.SU1, 2.15.08, 2.14.03.SU2, 2.15.08.SU3, 2.16.08, 7.4.SU3, 7.8, 7.8.SU1, and 7.8.SU2
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and country of Canada.
Product Description
IMPAX CV (Cardio Vascular) || The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting.
Manufacturer
AGFA Corp.
1 Event
- Recall of Device Recall Cardio Review Station (CRS)

Manufacturer

AGFA Corp.

Manufacturer Address
AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
Source
USFDA

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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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