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IMPAX Heart Station (2016-08-16)
- Starting date:
- August 16, 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-60146
Affected Products
IMPAX Heart Station
Reason
AGFA has determined that a software defect in Impax Heartstation initiates outbound workflows that happen at the point of reconciliation to move forward, even if the reconciliation has not been successful. Thus, corrective actions will be implemented to correct this defect.
Affected products
IMPAX Heart Station
Lot or serial number
Not applicable
Model or catalog number
- 1.4
- 1.4 SU01
- 1.5
- 1.5 SU01
- 1.5 SU02
- 1.5 SU03
- 1.6
- 1.6 SU01
- 1.7
Companies
- Manufacturer
-
AGFA Healthcare N.V.
Septestraat 27
Mortsel
2640
BELGIUM