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Health product recall

Syngo Dynamics - Server and Workstation Software (2014-02-20)

Starting date:
February 20, 2014
Posting date:
March 21, 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-38531

Recalled Products

  1. Syngo Dynamics - Server Software
  2. Syngo Dynamics-Workstation Software

Reason

On November 28, 2013 a complaint was reported to the manufacturer indicating that "when opening images for patient 'A', patient 'A' images show, but the report shows for a different patient 'B'. cardiologist is looking at the wrong hemodynamic report data.

Affected products

A. Syngo Dynamics - Server Software

Lot or serial number

10091862

Model or catalog number
  • 85162
  • 85182
  • 85257
Companies
Manufacturer
Siemens Medical Solutions USA Inc. Syngo US
51 Valley Stream Parkway
Malvern
19355
Pennsylvania
UNITED STATES

B. Syngo Dynamics-Workstation Software

Lot or serial number

10091863

Model or catalog number
  • 85162
  • 85182
  • 85257
Companies
Manufacturer
Siemens Medical Solutions USA Inc. Syngo US
51 Valley Stream Parkway
Malvern
19355
Pennsylvania
UNITED STATES