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Health product recall

SYNGO X WORKPLACE WORKSTATION AND SOFTWARE (2015-11-17)

Starting date:
November 17, 2015
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-56190

Affected Products

  1. SYNGO X WORKPLACE-WORKSTATION AND COMPUTER HARDWARE
  2. SYNGO X WORKPLACE-SOFTWARE

Reason

During regular testing at Siemens it was found that incorrect measurements in multi-planar reformattings (MPRS) of a volume were acquired with a CT scanner with a titled gantry.  In this situation, the "4d" tab card will incorrectly display length measurements that are too small, if the measurement has been performed at the upper right MPR in a 2x2 layout.

Affected products

A. SYNGO X WORKPLACE-WORKSTATION AND COMPUTER HARDWARE

Lot or serial number

12537

Model or catalog number

10281299

Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY

B. SYNGO X WORKPLACE-SOFTWARE

Lot or serial number

20060
20061

Model or catalog number

10502522

Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY