SYNGO DYNAMICS (2020-10-27)

Starting date:

October 27, 2020

Posting date:

November 13, 2020

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-74291

Last updated:
2020-11-13

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  Reason
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  Affected products

Affected Products

SYNGO DYNAMICS

Reason

Bug fixing and improvements for software addressing the following defects:

• When study is in progress sending the SR or creating a fetus in SD worksheet, data between multiple fetuses are being mixed together, omitted, or duplicated.
• VA20F fixup tool still completes fixup and merges study even if clicking ""X"" in upper corner on the possible merge dialog box.
• Misconfiguration of the syngo Dynamics product allowed approximately 500 legacy studies to be deleted from the SD database.

Affected products