Health product recall

Symbia T series Gamma Camera/CT Scanners System(2019-09-24)

Starting date:
September 24, 2019
Posting date:
October 25, 2019
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-71355

Last updated: 2019-10-25

Affected Products

  1. Symbia T series Gamma Camera/CT Scanners
  2. Symbia Intevo
  3. Symbia Evo Excel
  4. Intevo Bold

Reason

In a limited number of systems, the SK2 connector has double wires crimped to one terminal which may result in wires intermittently opening and coming off the pin terminal. There are two cables per system. This may result in loss of voltage to high voltage board located on the detectors. The effect of losing power is that no image can be made.

Affected products

A. Symbia T series Gamma Camera/CT Scanners

Lot or serial number

1149

Model or catalog number

10275010

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

B. Symbia Intevo

Lot or serial number
  • 2138
  • 2241
Model or catalog number
  • 10764803
  • 10764804
Companies
Manufacturer
Siemens Medical Solutions USA, Inc. Molecular Imaging
2501 North Barrington Road
Hoffman Estates
60192
Illinois
UNITED STATES

C. Symbia Evo Excel

Lot or serial number

1163

Model or catalog number

10910501

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

D. Intevo Bold

Lot or serial number
  • 1148
  • 2138
  • 2241
Model or catalog number

11007962

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