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MEDRAD MARK 7 ARTERION INJECTION SYSTEMS (2015-08-05)
- Starting date:
- August 5, 2015
- Posting date:
- September 24, 2015
- 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-54996
Affected Products
A. MEDRAD MARK 7 ARTERION INJECTION SYSTEM (TABLE MOUNT SYSTEM)
B. MEDRAD MARK 7 ARTERION INJECTION SYSTEM (PEDESTAL SYSTEM)
C. MEDRAD MARK 7 ARTERION INJECTION SYSTEM (CEILING MOUNT SYSTEM)
Reason
The manufacturer identified certain Medrad Mark 7 Arterion injection systems which utilize software version SW 005.006_SH, have a potential situation involving the purge enforcement procedure. In the absence of purge enforcement in Arterion software version SW 005.006_SH, users / technologists may not purge the fluid path.
Affected products
A. MEDRAD MARK 7 ARTERION INJECTION SYSTEM (TABLE MOUNT SYSTEM)
Lot or serial number
101149
20735
Model or catalog number
ART 700 TABL
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES
B. MEDRAD MARK 7 ARTERION INJECTION SYSTEM (PEDESTAL SYSTEM)
Lot or serial number
100785
Model or catalog number
ART 700 PEDL
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES
C. MEDRAD MARK 7 ARTERION INJECTION SYSTEM (CEILING MOUNT SYSTEM)
Lot or serial number
20422
Model or catalog number
ART 700 OCS
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES