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Spectris EP MR Injection System
- Starting date:
- February 15, 2017
- Posting date:
- February 28, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62418
Reason
It was discovered at the O'Hara site that operation manual CDs for Spectris Solaris EP (SSEP) were not sent to customers. The operation manual multilingual CD was intended to be placed on the product proposal which would have the manual shipped with the Spectris Solaris EP Injector as a line item. The CD was never added to the product proposal.
Affected products
Spectris EP MR Injection System
Lot or serial number
201188
201362
201380
201384
201398
201630
201643
201690
201828
201851
201852
201855
201867
202054
Model or catalog number
3012011
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES