SYNGO.PLAZA (2015-02-20)

Starting date:

February 20, 2015

Posting date:

March 20, 2015

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-52597

• Reason
• Affected products

Recalled products

1. SYNGO.PLAZA

Reason

A customer safety advisory notice is being issued to inform customers about a potential issue when using SYNGO.PLAZA. When using the pre-fetch/retrieve functionality from the archive (long term storage (LTS)) for a study where all the series have not yet been archived (e.g. due to late received series or archival time-out), these non-archived series will incorrectly get an archive flag set but will be protected from deletion. Therefore, it is possible that a user can manually remove the deletion protection in the short term storage (STS) from these non-archived series due to the impression that the whole study has been archived based on the archive flag being set. In this situation, there will be a partial data loss for the affected study.

Affected products