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BladderScan BVI 9600 and AortaScan AMI 9700 (2015-11-30)
- Starting date:
- November 30, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55982
Affected Products
A. BladderScan BVI 9600
B. AortaScan AMI 9700
Reason
Notification that use of medical device was not intended to include detection of abdominal aortic aneurysms (AAA). A negative result may underreport the actual diameter of a patient's abdominal aorta and may result in a false negative AAA detection.
Affected products
A. BladderScan BVI 9600
Lot or serial number
All lots.
Model or catalog number
BVI 9600 SYSTEM
Companies
- Manufacturer
-
Verathon Inc.
20001 NORTH CREEK PARKWAY
BOTHELL
98011
Washington
UNITED STATES
B. AortaScan AMI 9700
Lot or serial number
All lots.
Model or catalog number
AMI 9700 SYSTEM
Companies
- Manufacturer
-
Verathon Inc.
20001 NORTH CREEK PARKWAY
BOTHELL
98011
Washington
UNITED STATES