Devices

Device Recall Agfa IMPAX HeartStation ECG Management System

Model / Serial
Model number HeartStation 1.1 60+00091179 to 60+0091186; HeartStation Core Server 60+00091211; CV HeartStation EZKT7000, L9NBN000, EZKC000, L9NAL000, EZKWE000 and L9M9G000.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore
Product Description
AGFA IMPAX HeartStation ECG Management System.
Manufacturer
AGFA Corp.
1 Event
- Recall of Device Recall Agfa IMPAX HeartStation ECG Management System

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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