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Devices
IMPAX HEARTSTATION
Model / Serial
Model Catalog: 1.5 SU03 (Lot serial: n/a); Model Catalog: 1.5 SU01 (Lot serial: n/a); Model Catalog: 1.6 (Lot serial: n/a); Model Catalog: 1.5 (Lot serial: n/a); Model Catalog: 1.4 (Lot serial: n/a); Model Catalog: 1.6 SU01 (Lot serial: n/a); Model Catalog: 1.4 SU01 (Lot serial: n/a); Model Catalog: 1.5 SU02 (Lot serial: n/a); Model Catalog: 1.7 (Lot serial: n/a)
Product Description
IMPAX Heart Station
Manufacturer
AGFA HEALTHCARE INC.
1 Event
Recall of IMPAX HEARTSTATION
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Manufacturer
AGFA HEALTHCARE INC.
Manufacturer Address
MISSISSAUGA
Manufacturer Parent Company (2017)
Agfa-Gevaert NV
Source
HC
One device with a similar name
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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.
Language
English
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