Health product recall

Biograph 6 - Main Unit and Biograph LSO 16 Slice PET (2018-05-16)

Starting date:
May 16, 2018
Posting date:
June 22, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67074

Affected products

A. Biograph 6 - Main Unit
B. Biograph LSO 16 Slice PET

Reason

Siemens is notifying users of Biograph Systems of an issue that could potentially impact the CARE Dose4D algorithm in CT scans that include the head. An increase in dose is possible when scanning the head region with CARE Dose4D using a Posterior-Anterior (PA) or Anterior Posterior (AP) topogram. The customer letter includes instructions to avoid the issue.

Affected products

A. Biograph< 6 - Main Unit

Lot or serial number

44911

Model or catalog number

87 28 854

Companies
Manufacturer

Siemens Medical Solutions USA, Inc. Molecular Imaging

810 Innovation Drive

Knoxville

37932

Tennessee

UNITED STATES

B. Biograph LSO 16 Slice PET

Lot or serial number
  • 1052
  • 1313
  • 1317
  • 1402
  • 48450
  • P0007130-0401006
  • P0007130-0401008
Model or catalog number

87 28 581

Companies
Manufacturer

Siemens Medical Solutions USA, Inc. Molecular Imaging

810 Innovation Drive

Knoxville

37932

Tennessee

UNITED STATES