Devices

Device Recall Agfa HeartLab Cardiovascular DICOMstore

Model / Serial
DICOMstore, L9M8E, Software version: 2.04.40.00
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distributution - USA, including states of AZ, CA, DC, FL, IL, IN, KY, MA, ME, MN, MS, OH, OK, OR, NH, PA, SC, TN, TX, WI, and country of Canada.
Product Description
Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.
Manufacturer
AGFA Corp.
1 Event
- Recall of Device Recall Agfa HeartLab Cardiovascular DICOMstore

Manufacturer

AGFA Corp.

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

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