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Health product recall

SYNGO DYNAMICS VA10 VERSION (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 III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-57114

Affected Products

SYNGO DYNAMICS VA10 VERSION

Reason

Siemens is notifying syngo Dynamics customers of a potential issue when using the measurement package of the VA10 version. If two measurements with the same name exist, instances of measurement will populate both measurements definitions. One of the definitions can be edited while one cannot be seen or edited. Both set of measurements are used in any associated calculations. Therefore if you edit or delete one of the measurement instances the one that is hidden will not receive the edits and all instances, edited and not edited, will be averaged together.

Affected products

SYNGO DYNAMICS VA10 VERSION

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

VA10

Companies
Manufacturer
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY