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Stellant With Certegra Workstation - Stellant Ct
- Starting date:
- May 4, 2017
- Posting date:
- June 5, 2017
- 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-63480
Reason
Through a review of complaint data, it was identified that the workflow supported by versions 4.21, 4.31 and 4.32 of the Certegra Informatics point-of-care software may fail intermittently to send data captured from the injection system to the institution's PACS system. This failure to send data is more likely to occur when the Certegra workstation is left on for more than 24 consecutive hours.
Affected products
Stellant With Certegra Workstation - Stellant Ct
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
SCT-321
SCT-322
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES