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Health product recall

Biograph mCT-S Products (2016-12-15)

Starting date:
December 15, 2016
Posting date:
January 12, 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-61732

Affected Products 

  1. Biograph mCT-S with True V (64)
  2. Biograph mCT-S (40)
  3. Biograph mCT-Swith True V (40)

Reason

Siemens has become aware that some light marker windows on Biograph mCT and Biograph mCT Flow Systems may loosen and potentially drop out. In this case there is a risk that a person could touch the electrical or rotating parts of the gantry were they to reach through the window opening.

Affected products

  1. Biograph mCT-S with True V (64)

Lot or serial number

11030

Model or catalog number

10248672

Companies
Manufacturer
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES

B. Biograph mCT-S (40)

Lot or serial number

11044

Model or catalog number

10248668

Companies
Manufacturer
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES

C. Biograph mCT-Swith True V (40)

Lot or serial number

11058
11069

Model or catalog number

10248671

Companies
Manufacturer
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES