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IMPAX CV REPORTING (2016-03-08)
- Starting date:
- March 8, 2016
- Posting date:
- April 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58004
Affected products
A. IMPAX CV REPORTING
Reason
When more than one instance of outbound is running (either outbound.bat or outbound as a windows service), report mis-attribution can occur. The symptom is: for one study, patient information shows correctly on the preliminary report but shows a different patient on the final report.
This situation occurs if a system is accessed via non-console RDP connections. Batches or scripts placed in the startup folder (including outbound) of the corresponding domain user account are launched which can result in multiple sessions of outbound running at the same time. Multiple sessions of outbound running concurrently introduces the potential for data mis-attribution.
Affected products
A. IMPAX CV REPORTING
Lot or serial number
CV 7.4
CV 7.8
Model or catalog number
7.X
Companies
- Manufacturer
-
AGFA Healthcare N.V.
Septestraat 27
Mortsel
2640
BELGIUM