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SYNGO DYNAMICS (2017-12-01)
- Starting date:
- December 1, 2017
- Posting date:
- December 14, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65420
Affected products
SYNGO DYNAMICS
Reason
Siemens is notifying syngo Dynamics customers of a potential issue when a MOD (Method of Disks) or Doppler trace measurement is edited on an image on the workplace in syngo Dynamics. A potential exists for an extra instance of an output measurement to be added to the study (instead of replacing the current instance), which can affect the derived (mean) value of the result.
Affected products
SYNGO DYNAMICS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
VA10
VA20
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY