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Health product recall

Enterprise Imaging For Radiology

Starting date:
July 31, 2017
Posting date:
September 5, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-64386

Reason

The reason for this recall is to inform users about user errors and specific workflow scenarios on cancelled procedures that might result in an interrupted reporting workflow. This may lead to delayed diagnosis and treatment which in the worst case might result in no or inefficient treatment.

Affected products

Enterprise Imaging For Radiology

Lot or serial number

VERSION 8.0.0
VERSION 8.0.1
VERSION 8.1

Model or catalog number

8.X

Companies

Manufacturer
AGFA Healthcare N.V.
Septestraat 27
Mortsel
2640
BELGIUM