TOMTEC-ARENA (2019-09-21)

Starting date:

September 21, 2019

Posting date:

October 16, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71315

Last updated: 2019-10-16

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  Reason
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  Affected products

Affected Products

TOMTEC-ARENA

Reason

TOMTEC recently discovered a software issue associated with the image-com module/clinical application package (CAP) interface for 3D application in the TOMTEC-ARENA software, where measurements from one study might be stored to another study.

Affected products