Devices

Device Recall RM, RMAT

Model / Serial
Model No. L9M2100; Software Versions RM 2.08.12.00.00. All versions of the CV Reporting (RM) are now affected.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
AK, AZ, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI and Canada
Product Description
IMPAX CV Results Manager/Results Manager Administration Tool
Manufacturer
AGFA Corp.
1 Event
- Recall of Device Recall RM, RMAT

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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