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Enterprise Imaging (2017-11-27)
- Starting date:
- November 27, 2017
- Posting date:
- December 8, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-65358
Affected products
Enterprise Imaging
Reason
Additional addendums sent from enterprise imaging to an external RIS/HIS is sent with the same date/time-stamp in OBR-22 (results rpt/status chng - date/time) as the one from the first addendum. This may lead to addendum workflow issues. This issue may lead to the addendum not being stored in the RIS/HIS system and the addendum information not being considered by referring physicians/clinicians when making medical decisions.
Affected products
Enterprise Imaging
Lot or serial number
Not Applicable
Model or catalog number
8.0.0
8.0.1
8.1
8.1.1
Companies
- Manufacturer
-
AGFA Healthcare N.V.
Septestraat 27
Mortsel
2640
BELGIUM