Symbia T series Gamma Camera/CT Scanners (2019-07-12)

Starting date:

July 12, 2019

Posting date:

July 26, 2019

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-70527

Last updated: 2019-07-26

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  Reason
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  Affected products

Affected Products

Symbia T series Gamma Camera/CT Scanners

Reason

A defect in the broad quantification option of the Symbia product software version vb20a may cause the system not to retain:

1. The phantom volume entered by the user during volume sensitivity calibration.
2. The residual dose entered by the user during volume sensitivity calibration or acquisition.

The failure only occurs when broad quantification is purchased without other xSPECT Quant options. The software update vb20b service pack will eliminate the issue, correct other minor software problems and improve performance.

Affected products