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SYNGO IMAGING (2016-02-01)
- Starting date:
- February 1, 2016
- Posting date:
- February 12, 2016
- 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-57116
Affected Products
SYNGO IMAGING
Reason
Siemens is notifying customers using syngo Imaging Studio / advanced Studio version VB36C and older of the possibility of incorrect values for distance measurement. For measurement calculation, syngo Imaging VB36C and older version use the DICOM attribute "imager pixel spacing" (Tag (0018, 1164)) instead of "pixel spacing" (Tag (0028, 0030)). This may result in incorrect values for distance measurements. This happens if both DICOM attributes "imager pixel spacing" and "pixel spacing" are set and have different values.
Affected products
SYNGO IMAGING
Lot or serial number
- 1094
-
1200
Model or catalog number
10 014 063
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY