OrthoScan HD Model 1000 Mini C-Arm X-Ray System and OrthoScan Mobile DI Mini C-Arm X-Ray System (2018-02-05)
- Starting date:
- February 5, 2018
- Posting date:
- February 9, 2018
- 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-65936
Affected products
- OrthoScan HD Model 1000-0001 Mini C-arm X-Ray System
- OrthoScan HD Model 1000-0004 Mini C-Arm X-Ray System
- OrthoScan Mobile DI Mini C-Arm X-Ray System
Reason
Devices do not meet IEC/EN 60601-2-54 203.8.5.3 with respect to use of the Digital Zoom Mode if user follows a non-standard workflow. The system will expose a larger X-Ray field than allowed beyond the image receptor field of view displayed on the monitor of the system by > 3% of SID. Known Aug 2017.
Affected products
A. OrthoScan HD Model 1000-0001 Mini C-arm X-Ray System
Lot or serial number
All lots.
Model or catalog number
1000-0001
Companies
- Manufacturer
-
OrthoScan Inc.
8212 East Evans Road
Scottsdale
85260
Arizona
UNITED STATES
B. OrthoScan HD Model 1000-0004 Mini C-Arm X-Ray System
Lot or serial number
All lots.
Model or catalog number
1000-0001
1000-0004
1000-0004-FD
Companies
- Manufacturer
-
OrthoScan Inc.
8212 East Evans Road
Scottsdale
85260
Arizona
UNITED STATES
C. OrthoScan Mobile DI Mini C-Arm X-Ray System
Lot or serial number
All lots.
Model or catalog number
1000-0005
Companies
- Manufacturer
-
OrthoScan Inc.
8212 East Evans Road
Scottsdale
85260
Arizona
UNITED STATES