Siemens Server and Workstation Software (2014-04-11)

Starting date:

April 11, 2014

Posting date:

April 30, 2014

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-39255

• Reason
• Affected products

Recalled Products

A. Server Software
B. Workstation Software

Reason

A potential issue when using "in-progress" invasive reporting with sensis integration to Syngo Dynamics version 9.5.  The issue occurs under the following conditions:

• Sensis-Syngo dynamics integration
• Sensis study is opened from Syngo dynamics while still "in-progress"
• Sensis reference numbers greater than 1,000,000
• Sensis reference numbers grow in response to HL7 messages, even if those HL7 messages are not being utilized by Sensis and/or Syngo Dynamics.

Sensis reference numbers greater than 1,000,000 are wrongly modified during transfer to Syngo Dynamics. When this happens during "in-progress" reporting, a study will get a Sensis reference number for the wrong study in sensis. This causes an incorrect 'link' between the Syngo Dynamics images and the Sensis study data.  If this happens, customers will have to call Siemens service team. There has not been any patient consequence reported from the installed base.

Affected products