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Spectris EP MR Injection System
- Starting date:
- January 16, 2017
- Posting date:
- February 1, 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-62056
Reason
The battery/cable power assemblies in Spectris Solaris EP MR Injection Systems (SSEP) distributed from September - November 2016 do not meet our specifications. This could result in intermittent power failure of the device which could result in a degraded image or a delay of the imaging procedure requiring a repeat of the contrast-enhanced MR scan should it occur during a procedure.
Affected products
Spectris EP MR Injection System
Lot or serial number
SN 202054
Model or catalog number
3012011
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES