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Health product recall

Axiom Sensis Hemodynamic Application (2017-04-17)

Starting date:
April 17, 2017
Posting date:
June 5, 2017
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-63462

Affected Products

A. Axiom Sensis XP System-Hemodynamic Application
B. Axiom Sensis System-Hemodynamic Application

Reason

In Sensis System, a computer that is extremely dusty can cause problems when starting the system. In rare cases, it can cause the Sensis to fail. Should the Sensis System fail, its functions can no longer be used. Clinical treatment may need to be terminated, restarted or transferred to a functioning system.

Affected products

A. Axiom Sensis XP System-Hemodynamic Application

Lot or serial number

All lots

Model or catalog number

6634633

Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY

B. Axiom Sensis System-Hemodynamic Application

Lot or serial number

All lots

Model or catalog number

6634633

Companies
Manufacturer
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY