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Health product recall

Somatom Definition AS-Main Unit

Starting date:
October 24, 2016
Posting date:
November 9, 2016
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-60958

Affected Products

Reason

While performing a service call, it was identified that a Somatom Definition AS was missing the laser windows on the gantry front cover.
It was identified that due to the gantry cover opening, there is a risk for severe injury of the patient if he/she is to use the opening for stabilization or for support.
Further investigation revealed that the Somatom Definition AS and the Somatom Definition Flash were affected.

Affected products

SOMATOM DEFINITION AS-MAIN UNIT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

8098027

Companies
Manufacturer
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY