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IMPAX CARDIOVASCULAR (2015-08-28)
- Starting date:
- August 28, 2015
- Posting date:
- October 5, 2015
- 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-55198
Affected Products
- IMPAX CARDIOVASCULAR - DIAGNOSTIC REVIEW STATION
- IMPAX CARDIOVASCULAR - CLINICAL REVIEW STATION
Reason
The reason for this recall/correction is to inform users a software issue, that requires correction, has been found in the demographics manager feature of IMPAX CV software. In specific circumstances, a patient's report generated by the demographics manager service may be populated with demographic data from a different patient's report.
Affected products
A. IMPAX CARDIOVASCULAR - DIAGNOSTIC REVIEW STATION
Lot or serial number
All lots.
Model or catalog number
- 12.0
- 12.1
- 12.2
- 7.8
Companies
- Manufacturer
-
AGFA Healthcare N.V.
Septestraat 27
Mortsel
2640
BELGIUM
B. IMPAX CARDIOVASCULAR - CLINICAL REVIEW STATION
Lot or serial number
All lots.
Model or catalog number
- 12.0
- 12.1
- 12.2
- 7.8
Companies
- Manufacturer
-
AGFA Healthcare N.V.
Septestraat 27
Mortsel
2640
BELGIUM